NewDirector, Regulatory Affairs, Ex-US Larimar TherapeuticsDirector, Regulatory Affairs, Ex-USPhiladelphia, PAPrepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
LEGISLATIVE AND REGULATORY AFFAIRS DIRECTOR AT HOUSING CALIFORNIA Axis Talent PartnersLEGISLATIVE AND REGULATORY AFFAIRS DIRECTOR AT HOUSING CALIFORNIAFlorin, CAWe bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stable, affordable homes, and reverse the legacy of systemic racial and economic inequities by building power among the people most impacted by housing injustice in partnership with cross-sector partners, shaping the narrative, and advocating for the passage of transformative statewide policy solutions. The position is expected to participate in regular travel (mostly in California) including the following engagements: twice yearly Board of Directors meetings (sometimes held in Sacramento); annual 2-3 day staff retreat; annual 3-day Housing California conference (often in Sacramento); annual 2-3-day statewide RUN summit (sometimes in Sacramento); plus various conferences or in-person partner meetings, based on need and interest.
NewExecutive Director, US Medical Affairs, Oncology Solid Tumor Lead Jazz PharmaceuticalsExecutive Director, US Medical Affairs, Oncology Solid Tumor LeadPhiladelphia, PARemote$304,000–$456,000 / yearThis role will be the strategic partner for the Oncology Solid Tumor Commercial Lead and collaborate extensively on the design and execution of deployment of field colleagues in support of the therapeutic space, including the design and execution of account-level cross-functional collaboration, quality engagement, field and payer value, evidence strategy and execution, and serve as an SME in compliant medical design. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewSr. Director, Global Labeling Strategy CSL BehringSr. Director, Global Labeling StrategyKing of Prussia, PADue to the global nature of the position, the Head of Global Labeling Strategy engages cross-functionally with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial Development, Medical Affairs and Market Access to ensure business critical objectives are met and scientific, regulatory compliant labeling is provided to Health Care Professionals. Works closely with the TA Heads, GRA GRS to maintain an effective, globally-minded, Global Regulatory Affairs and Safety organization that is focused on utilizing creative problem-solving skills, can clearly articulate the science / regulatory perspective to stakeholders, and contributes to the overall TA Strategy for each TA.
NewAssociate Medical Director, Medical Safety Jazz PharmaceuticalsAssociate Medical Director, Medical SafetyPhiladelphia, PARemote$212,000–$318,000 / yearServe as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products. Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
NewMedical Director, Medical Safety Jazz PharmaceuticalsMedical Director, Medical SafetyPhiladelphia, PARemote$256,000–$384,000 / yearSupport signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.
NewDirector, Clinical Development, Neuroscience Jazz PharmaceuticalsDirector, Clinical Development, NeurosciencePhiladelphia, PARemote$196,000–$294,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of clinical trials and programs.
NewSenior Director, Oncology Pharmacology Jazz PharmaceuticalsSenior Director, Oncology PharmacologyPhiladelphia, PARemote$232,000–$348,000 / yearPrimary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.
NewDirector, Business Development Larimar TherapeuticsDirector, Business DevelopmentPhiladelphia, PAThe successful candidate will have a deep understanding of business and market dynamics, transactions and partnerships, a track record of developing and executing successful corporate strategies, robust understanding of finance, and the ability to work collaboratively with cross-functional teams. Foster collaborative and supportive cross-functional working relationships, including engaging the senior leadership team in the development and prioritization of long-term strategies and acting as a thought partner with the business to make effective and timely decisions .
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationRadnor, PA$157,500–$262,500 / yearExperience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.
Director of Regulatory Affairs Avalo TherapeuticsDirector of Regulatory AffairsPhiladelphia, PAThe Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for abdakibart (AVTX-009), the company's lead asset, as it advances into Phase 3, and potential registration.
NewAccounting Associate Jewish Federation of Greater PhiladelphiaAccounting AssociatePhiladelphia, PAReporting to the the Director of EITC (Educational Improvement Tax Credit) and working closely with the Director, Finance Department, and the Fundraising department's EITC Committee, the Accounting Associate supports core program workflows, regulatory compliance, and data-driven decision-making. The responsibilities include processing donations, producing financial reports, tracking and verifying scholarship allocations, regulatory compliance, supporting program operations, and stakeholder engagement.
Director, Regulatory Affairs ICON PlcDirector, Regulatory AffairsBlue Bell, PAAs a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
NewDirector, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesNorth Wales, PA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Director Regulatory Affairs Innovative Medicines (IM) Labeling Teva Pharmaceutical Industries LtdDirector Regulatory Affairs Innovative Medicines (IM) LabelingWest Chester, PAAdditional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. Thorough familiarity with: Structured Product Labeling (SPL) and drug listing; Company Core Data Sheet (CCDS) and Company Core Safety Information (CCSI) documents; Summary of Product Characteristics (SmPC); document management systems.
Executive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsPA$255,800–$402,700 / year10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineUpper Gwynedd, PA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonNorth Wales, PA$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyCollegeville, PA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Director, Regulatory Affairs - CMC ICON PlcDirector, Regulatory Affairs - CMCBlue Bell, PARemoteWe are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience. As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.
Director, CMC Regulatory Affairs GSK plcDirector, CMC Regulatory AffairsCollegeville, PAGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Assoc Director, Regulatory Affairs - Advertising and Promotion Merck & Co IncAssoc Director, Regulatory Affairs - Advertising and PromotionNorth Wales, PA$129,000–$203,100 / yearRequired Skills: Clinical Trials, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Electronic Common Technical Document (eCTD), FDA Regulations, Negotiation, Pharmaceutical Industry, Promotional Review, Regulatory Compliance, Regulatory Labeling, Regulatory Strategies, Regulatory Submissions, Stakeholder Management, Strategic Thinking, US Regulatory Affairs. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
AD/ Director, Clinical Regulatory Affairs Gene Therapy Ocugen IncAD/ Director, Clinical Regulatory Affairs Gene TherapyMalvern, PAThis individual will help shape regulatory strategy for innovative therapies intended to address serious unmet medical needs and will work closely with executive leadership, Clinical Development, Clinical Operations, Medical Affairs, and Regulatory teams to support accelerated pathways toward potential approval and commercialization. This is a unique opportunity to contribute meaningfully to multiple gene therapy programs at a pivotal stage of growth, with direct exposure to FDA and global health authority interactions, cross-functional development strategy, and late-stage regulatory planning.
Senior Director, Regulatory Affairs REMS Program Cytokinetics IncSenior Director, Regulatory Affairs REMS ProgramRadnor, PA$263,880–$307,860 / yearReporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution related to Risk Evaluation and Mitigation Strategy (REMS) and providing regulatory compliance oversight for REMS. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Director of Academic Affairs and Student Success Temple UniversityDirector of Academic Affairs and Student SuccessPhiladelphia, Pennsylvania$90,000–$100,000University College supports Temple's mission by providing high quality education to its students that is accessible, affordable, diverse, and engaged with the broader community across its campuses at Ambler, Center City, Harrisburg, Main Campus, and online. The Director of Academic Affairs and Student Success provides leadership and operational oversight for academic programming and student success initiatives across the University College and its campuses, with a primary focus on the Bachelor of General Studies.
Regulatory Affairs Specialist, Global Quaker Chemical CorpRegulatory Affairs Specialist, GlobalPASupport chemical regulatory activities related to documentation, including updating raw material information, communicating changes to raw material classifications, data management, and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.
Regulatory Affairs Specialist, Global Quaker HoughtonRegulatory Affairs Specialist, GlobalConshohocken, PASupport chemical regulatory activities related to documentation including updating raw material information, communicating changes to raw material classifications, data management and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.
Mgr, Product Stewardship & Regulatory Affairs AGC IncMgr, Product Stewardship & Regulatory AffairsExton, PAThis role operates within a global CSR and product stewardship organization and is critical to enabling new product commercialization, maintaining regulatory compliance for existing products, and supporting long-term business growth. • Supports and progressively leads new product registrations in the Americas, including TSCA PMNs, LVEs, Polymer Exemptions, Canadian DSL/NDSL notifications, and TSCA Sections 8(c)/8(e) evaluations.
Senior Director, Team Lead US Medical Affairs, COPD Merck & Co IncSenior Director, Team Lead US Medical Affairs, COPDNorth Wales, PA$210,400–$331,100 / yearRequired Skills: Chronic Obstructive Pulmonary Disease (COPD), Clinical Practice, Clinical Research, Medical Affairs, Pharmaceutical Medical Affairs, Pharmacy Practice, Respiratory Diseases Treatment, Respiratory Pharmacology, Team Leadership. Excellent interpersonal communication and presentation skills, strong personal integrity, teamwork abilities (including the ability to lead a therapeutic team across a geographical area), business acumen, and focus on scientific education and dialogue.
Health Systems Oncology Medical Affairs Director (HSO MAD) - Texas/Louisiana/New Mexico Merck & Co IncHealth Systems Oncology Medical Affairs Director (HSO MAD) - Texas/Louisiana/New MexicoNorth Wales, PARemote$210,400–$331,100 / year3 years of dedicated experience in a field-based MA role working with regional and/or national payers, integrated delivery systems, or scientific leaders OR 5 years of clinical oncology experience working within a health system OR the equivalent. Serves as the primary resource for market dynamics within the territory to understand decision makers' evolving information needs to feed into the ongoing value-proposition development process for oncology product and non-product offerings.
Associate Director, US Medical Affairs - Autoantibody Neuroimmunology Johnson & JohnsonAssociate Director, US Medical Affairs - Autoantibody NeuroimmunologyHorsham, PAContributes to US Autoantibody Neuroimmunology Medical Affairs strategy, working cross-functionally with partners within the Integrated evidence team (IET), including RWV&E, IET Leads, SCG, Marketing brand teams, as well as potentially Disease Area Stronghold (DAS), R&D, Global Medical Affairs, Medical Science Liaison (MSL) and Global Commercial partners to promote and execute the TA Strategy for establishing access as well as evidence generation and dissemination. Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) Neuroimmunology drugs and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners).
Medical Director, Dermatology- US Medical Affairs Johnson & JohnsonMedical Director, Dermatology- US Medical AffairsHorsham, PennsylvaniaContribute to US Dermatology Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the Dermatology IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Dermatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Dermatology TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans. Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials, registries, real-world evidence, and collaborations by leading study design, protocol development, analysis plan development, and providing overall trial leadership (including execution, monitoring, supervision, compliance, and risk identification/ mitigation).
Regional Government Affairs Director - Northeast ModivCare Inc.Regional Government Affairs Director - NortheastPA$159,900–$215,900 / yearThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the companys primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
NewDirector, Reg & Scientific Affairs Johnson & JohnsonDirector, Reg & Scientific AffairsWest Chester, MassachusettsBusiness Alignment, Business Architecture, Business Process Design, Business Savvy, Computer Programming, Developing Others, Human-Computer Interaction (HCI), Inclusive Leadership, Leadership, Platform as a Service (PaaS), Product Knowledge, Program Management, Software Development Management, Strategic Change, Succession Planning, Tactical Planning, Technical Credibility . Lead the application of AI, advanced analytics, and automation to modernize R&D platforms, accelerating product development, improving scientific and engineering insights, and strengthening end‑to‑end decision‑making while enabling scalable, compliant, and efficient R&D operations from discovery through lifecycle management.
Medical Director, Dermatology- US Medical Affairs 6120-Janssen Scientific Affairs Legal EntityMedical Director, Dermatology- US Medical AffairsHorsham, PennsylvaniaContribute to US Dermatology Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the Dermatology IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Dermatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Dermatology TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans. Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials, registries, real-world evidence, and collaborations by leading study design, protocol development, analysis plan development, and providing overall trial leadership (including execution, monitoring, supervision, compliance, and risk identification/ mitigation).
Senior Director, Field Medical Affairs Team Lead Cabaletta Bio IncSenior Director, Field Medical Affairs Team LeadPhiladelphia, PAThis leader will play a critical role in shaping field medical strategy, generating scientific insights, and establishing strong relationships with trial investigators, key opinion leaders (KOLs) and cell therapy treatment centers in a highly specialized and evolving therapeutic area. We are seeking a highly motivated and experienced Senior Director, Field Medical Affairs Team Lead to lead the strategic development, build-out, and execution of the field medical organization in support of rese-cel in myositis and other autoimmune diseases.
NewDirector, Reg & Scientific Affairs 6149-DePuy Synthes Products Legal EntityDirector, Reg & Scientific AffairsWest Chester, MassachusettsBusiness Alignment, Business Architecture, Business Process Design, Business Savvy, Computer Programming, Developing Others, Human-Computer Interaction (HCI), Inclusive Leadership, Leadership, Platform as a Service (PaaS), Product Knowledge, Program Management, Software Development Management, Strategic Change, Succession Planning, Tactical Planning, Technical Credibility . Lead the application of AI, advanced analytics, and automation to modernize R&D platforms, accelerating product development, improving scientific and engineering insights, and strengthening end‑to‑end decision‑making while enabling scalable, compliant, and efficient R&D operations from discovery through lifecycle management.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemotePhiladelphia, PARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Regulatory Affairs Manager Regulatory Reporting Essity ABRegulatory Affairs Manager Regulatory ReportingPhiladelphia, PAEssity's Digital Transformation & Business Enablement team is looking for an experienced Regulatory Affairs Manager focused on North American regulatory reporting across all business units related to various topics including packaging regulations, chemical regulations, etc. As an employee at Essity, you will belong to a team where you feel valued, are safe, supported to grow and challenged to generate business results in a friendly and open atmosphere.
Associate Medical Director, US Medical Affairs, Dermatology Johnson & JohnsonAssociate Medical Director, US Medical Affairs, DermatologyPAKey Responsibilities Contributes to US Derm Medical Affairs strategy and will actively contribute to one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the IETs, including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing brand teams, as well as potentially Derm Disease Area Stronghold (DAS), R&D, Global Medical Affairs, (MSL) and Global Commercial partners to support execution of the TA Strategy for establishing access as well as plans for evidence generation and dissemination plans. Contributes as a subject matter expert on analysis of key data in support of US Immunology for approved or planned therapies and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners) Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, with a focus on efficacy, outcomes, and safety/adverse event analyses.
Associate Director, Medical Affairs - GI Merck & Co IncAssociate Director, Medical Affairs - GINorth Wales, PA$173,200–$272,600 / yearAdvance degree (e.g., MS, PharmD, PhD) in life sciences or a related field and a minimum of 2-3 years of experience in medical education, professional relations, medical affairs, or the pharmaceutical industry -OR- BA/BS degree in life sciences or a related field and a minimum of 5 years of experience in medical education, professional relations, medical affairs, or the pharmaceutical industry. This role is responsible for operational delivery, relationship management, and cross-functional coordination within an assigned TA, project, or region, while ensuring compliant, high-quality execution that advances the company's scientific and medical objectives.
Global Medical Affairs and Strategic Alliances Director Merck & Co IncGlobal Medical Affairs and Strategic Alliances DirectorUpper Gwynedd, PA$190,800–$300,300 / yearThe Global Medical Affairs and Strategic Alliances Director works closely with the Global and/or Regional Medical Affairs Leads, Commercial Teams, including Commercial Alliance Management, Global Medical and Value Capabilities, and Clinical Development to internally coordinate alliance MA activities, inform all major stakeholders of unmet needs, and facilitate approaches to address them. Exceptional ability to effectively communicate information (verbal and written) to internal and external stakeholders at all levels (e.g., senior leadership, management and individual contributor) and create presentation concepts and slides that are visually appealing with compelling content.
Associate Medical Director, US Medical Affairs, Dermatology 6120-Janssen Scientific Affairs Legal EntityAssociate Medical Director, US Medical Affairs, DermatologyHorsham, PennsylvaniaContributes to US Derm Medical Affairs strategy and will actively contribute to one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the IETs, including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing brand teams, as well as potentially Derm Disease Area Stronghold (DAS), R&D, Global Medical Affairs, (MSL) and Global Commercial partners to support execution of the TA Strategy for establishing access as well as plans for evidence generation and dissemination plans. The Associate Medical Director US Medical Affairs - Dermatology will report to the Head (Senior Director), Dermatology, US Medical Affairs - Immunology, and be an important part of the Dermatology TA team, working closely with the other Dermatology Medical Directors (and Associate Directors) as well as partners in US and Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology, R&D, Biostatistics, and US and Global Commercial Team members supporting Immunology and Dermatology within the Johnson & Johnson organization.
Associate Director, US Medical Affairs – Autoantibody Neuroimmunology 6120-Janssen Scientific Affairs Legal EntityAssociate Director, US Medical Affairs – Autoantibody NeuroimmunologyHorsham, PennsylvaniaContributes to US Autoantibody Neuroimmunology Medical Affairs strategy, working cross-functionally with partners within the Integrated evidence team (IET), including RWV&E, IET Leads, SCG, Marketing brand teams, as well as potentially Disease Area Stronghold (DAS), R&D, Global Medical Affairs, Medical Science Liaison (MSL) and Global Commercial partners to promote and execute the TA Strategy for establishing access as well as evidence generation and dissemination. The Associate Medical Director US Medical Affairs -Autoantibody Neuroimmunology will report to the Head, Autoantibody Neuroimmunology US Medical Affairs- Immunology, and be an important part of the Autoantibody Neuroimmunology TA team, working closely with the other Medical Directors and Associate Directors as well as partners in Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology, R&D, Biostatistics, and US and Global Commercial Team members supporting Immunology and Autoantibody within the Johnson & Johnson organization.
SVP, Head of Government Affairs and Public Policy Safelite Group, Inc.SVP, Head of Government Affairs and Public PolicyPhiladelphia, PAThis role provides executive leadership across lobbying, policy research and analysis, advocacy, political engagement, and regulatory strategy, while building and sustaining trusted relationships with policymakers, regulators, industry associations, OEMs, clients, and internal stakeholders. The SVP, Head of Government Affairs and Public Policy serves as Safelite's most senior government affairs and public policy leader, responsible for developing and executing a comprehensive strategy to shape public policy, influence legislative and regulatory outcomes, and advance the company's business objectives at the federal, state, and local levels.
Associate Director, State Government Affairs Financial Industry Regulatory Authority IncAssociate Director, State Government AffairsPhiladelphia, PAFINRA employees are required to disclose to FINRA all brokerage accounts that they maintain, and those in which they control trading or have a financial interest (including any trust account of which they are a trustee or beneficiary and all accounts of a spouse, domestic partner or minor child who lives with the employee) and to authorize their broker-dealers to provide FINRA with duplicate statements for all of those accounts. Additional insurance includes basic life, accidental death and dismemberment, supplemental life, spouse/domestic partner and dependent life, and spouse/domestic partner and dependent accidental death and dismemberment, short- and long-term disability, long-term care, business travel accident, disability and legal.
Medical Director, Autoantibody, Pipeline - US Medical Affairs Johnson & JohnsonMedical Director, Autoantibody, Pipeline - US Medical AffairsHorsham, PennsylvaniaContribute to US Autoantibody Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Autoantibody products/indications, working cross-functionally with partners within the Autoantibody IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Autoantibody Disease Area Stronghold, R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Autoantibody TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans. Additionally, the Medical Director will partner with colleagues on real-world evidence, health economic and outcomes research, biostatistics, and work with commercial marketing colleagues through integrated evidence teams and other touchpoints to formulate and execute activities in support of the Autoantibody TA strategy across the asset, prioritizing key indications, with a focus on maternal fetal medicine and warm autoimmune hemolytic anemia.
Director, Government Affairs Philadelphia Orchestra AssociationDirector, Government AffairsPhiladelphia, PAp>Representing both the world-renowned Philadelphia Orchestra and a dynamic roster of resident partners and visiting artists, POEA presents more than one-thousand events annually that represent a wide range of programming, including Broadway, classical, comedy, theater, jazz, dance, and family presentations, reflecting and serving the breadth of the region's communities. As owner and operator of the Academy of Music, Miller Theater, and the Kimmel Center for the Performing Arts, and the programming partner for the historic Forrest Theatre, POEA serves as a cornerstone of the city's artistic and civic identity, welcoming one million people annually to a vibrant constellation of stages across Center City.
Medical Director, Autoantibody, Pipeline - US Medical Affairs 6120-Janssen Scientific Affairs Legal EntityMedical Director, Autoantibody, Pipeline - US Medical AffairsHorsham, PennsylvaniaContribute to US Autoantibody Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Autoantibody products/indications, working cross-functionally with partners within the Autoantibody IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Autoantibody Disease Area Stronghold, R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Autoantibody TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans. Additionally, the Medical Director will partner with colleagues on real-world evidence, health economic and outcomes research, biostatistics, and work with commercial marketing colleagues through integrated evidence teams and other touchpoints to formulate and execute activities in support of the Autoantibody TA strategy across the asset, prioritizing key indications, with a focus on maternal fetal medicine and warm autoimmune hemolytic anemia.