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.
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.
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, 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.
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.
NewRegulatory Affairs Director IQVIA Holdings IncRegulatory Affairs DirectorWayne, PA$128,800–$358,800 / yearThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.
NewDirector, Global Regulatory Affairs & Clinical Safety Business Development Merck & Co IncDirector, Global Regulatory Affairs & Clinical Safety Business DevelopmentNorth Wales, PA$173,200–$272,600 / yearWork with the staff to manage the strategy, negotiation, and provisions of regulatory components of agreements as they relate to product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures. More specifically, this position will oversee staff who will manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of regulatory activities relating to our Company business partner deals.
NewSenior Director of Medical Affairs B. Braun Medical LtdSenior Director of Medical AffairsPA$200,000–$300,000 / yearThe targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. This executive leader will drive clinical and safety strategy, ensure regulatory compliance, and partner with R&D, Regulatory, Commercial, and Global Medical Affairs teams to shape product development and lifecycle management.
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.
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.
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.
Senior Director, Regulatory Affairs REMS Program CytokineticsSenior Director, Regulatory Affairs REMS ProgramRadnor, CaliforniaReporting to the Executive Director, Regulatory Affairs, the Senior Director, RegulatoryAffairs, 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.
Executive Director, US Medical Affairs, Oncology Solid Tumor Lead Jazz Pharmaceuticals PlcExecutive 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.
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.
Principal Scientist (Director) - Regulatory Affairs-CMC Merck & Co IncPrincipal Scientist (Director) - Regulatory Affairs-CMCNorth Wales, PA$190,800–$300,300 / yearThe Principal Scientist / Director responsibilities include but are not limited to: • Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products. Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organizations biologics product franchises in accordance with domestic and international regulations and guidance.
Medical Director, Dermatology- US Medical Affairs Johnson & JohnsonMedical Director, Dermatology- US Medical AffairsPAContribute 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.
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).
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.
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.
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 Medical Director, US Medical Affairs, Dermatology Johnson & JohnsonAssociate 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.
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.
Medical Director, Autoantibody, Pipeline - US Medical Affairs Johnson & JohnsonMedical Director, Autoantibody, Pipeline - US Medical AffairsPAContribute 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.
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.
Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs Johnson & JohnsonMedical Director, Gastroenterology Therapeutic Area, US Medical AffairsHorsham, Pennsylvaniaby leading one or more approved and pipeline GI products/indications Integrated Evidence Teams (IETs), working cross-functionally with partners within the GI Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing team brand leads, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs and Global Commercial partners to promote and execute the GI TA Strategy for establishing access as well as plans for and progress and outcomes for evidence generation activities and Data Dissemination Plans. Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) GI 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).
NewRegulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerPhiladelphia, PAThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Regulatory Affairs Manager CMC CSL Behring LLCRegulatory Affairs Manager CMCKing of Prussia, PAThat collaboration shapes the high-quality, compliant CMC regulatory submissions you'll manage end-to-end- new marketing applications, clinical trial applications, variations, supplements, periodic compliance reports, and renewals - each one needing to be technically sound and built to withstand regulatory scrutiny. As a Regulatory Affairs Manager CMC you will drive regulatory CMC strategy for your assigned products, spanning both development and commercial stages, working closely with colleagues across Global Regulatory Affairs CMC, R&D, Quality, and Global Operations.
Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs 6120-Janssen Scientific Affairs Legal EntityMedical Director, Gastroenterology Therapeutic Area, US Medical AffairsHorsham, Pennsylvaniaby leading one or more approved and pipeline GI products/indications Integrated Evidence Teams (IETs), working cross-functionally with partners within the GI Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing team brand leads, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs and Global Commercial partners to promote and execute the GI TA Strategy for establishing access as well as plans for and progress and outcomes for evidence generation activities and Data Dissemination Plans. Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) GI 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).
Regulatory Affairs Manager Lanxess AGRegulatory Affairs ManagerPittsburgh, PALANXESS has achieved leading positions in the Dow Jones Best-in-Class Index and the MSCI ESG and ISS ESG ratings, among others, for its commitment to sustainability. 5 to 10 years experience in the regulatory field with technical knowledge of the current FIFRA and PMRA regulatory requirements, procedures and guidelines for Registration of biocides by the U.S. EPA, state agencies and PMRA.
Global Medical Affairs Leader Psoriatic Disease 6085-Janssen Global Services Legal EntityGlobal Medical Affairs Leader Psoriatic DiseaseHorsham, PennsylvaniaIn close collaboration with Regional Medical Affairs, GMA Strategy and Execution, and Clinical Development, the GMAL develops integrated medical strategies and cross-regional plans that support asset development and worldwide execution. The Global Medical Affairs Leader (GMAL) for Psoriatic Disease (Director) leads global medical affairs strategy, clinical-commercial optimization, and lifecycle planning for icotrokinra and pipeline assets.
Associate Director - Life Sciences Advisory - Medical Affairs/Real World Evidence (RWE) Guidehouse IncAssociate Director - Life Sciences Advisory - Medical Affairs/Real World Evidence (RWE)PA$135,000–$225,000 / yearGuidehouse's Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device, and diagnostic companies develop custom solutions that tackle today's challenges, while anticipating tomorrow's. 3+ years of experience leading project engagements which includes planning, scoping, budget development, management and resource allocation, and managing multiple or more complex projects within scope, timeline and budget.
Program Manager, Regulatory Affairs Olympus CorpProgram Manager, Regulatory AffairsPAResponsible for maintenance of regulatory files and tracking databases toensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
Quality and Regulatory Affairs Manager DENTALEZQuality and Regulatory Affairs ManagerLancaster, PAFull timeEnsures that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures. Advisespersonnel and projectteams on quality system and regulatoryrequirements, coordinatesand presentsregulatoryinformation, and negotiates with and influencesmanagement and colleagues to ensurerequirementsare met.
Global Medical Affairs Leader Psoriatic Disease Johnson & JohnsonGlobal Medical Affairs Leader Psoriatic DiseasePAPurpose: The Global Medical Affairs Leader (GMAL) for Psoriatic Disease (Director) leads global medical affairs strategy, clinical-commercial optimization, and lifecycle planning for icotrokinra and pipeline assets. In close collaboration with Regional Medical Affairs, GMA Strategy and Execution, and Clinical Development, the GMAL develops integrated medical strategies and cross-regional plans that support asset development and worldwide execution.
Head, Therapeutic Area Lead Rheumatology, US Medical Affairs- Immunology Johnson & JohnsonHead, Therapeutic Area Lead Rheumatology, US Medical Affairs- ImmunologyPAActively contribute as a disease-specific subject matter expert and provide advice and input to and support the Global Medical Affairs, R&D, Marketing, Sales, Market Access, New Business Development, Real World Value & Evidence, MSL training and resource development, Medical Information and Communications teams, shaping and influencing the collective strategy based on sound scientific principles, available data, and strategic insights. The Head, Therapeutic Area Lead Rheumatology will represent Medical Affairs leadership in this therapeutic area by identifying and addressing key stakeholders' needs through data generation, data dissemination, and special initiatives supporting our Rheumatology products.
Manager II, Regulatory Affairs Strategy Alcon IncManager II, Regulatory Affairs StrategyPA$105,000–$175,000 / yearYou will support regulatory strategy execution with a focus on medical device consumables and accessories within the Surgical franchise, partnering cross‑functionally to ensure alignment with evolving regulatory expectations. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemotePhiladelphia, PARemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
Head, Therapeutic Area Lead Rheumatology, US Medical Affairs- Immunology 6120-Janssen Scientific Affairs Legal EntityHead, Therapeutic Area Lead Rheumatology, US Medical Affairs- ImmunologyHorsham, PennsylvaniaActively contribute as a disease-specific subject matter expert and provide advice and input to and support the Global Medical Affairs, R&D, Marketing, Sales, Market Access, New Business Development, Real World Value & Evidence, MSL training and resource development, Medical Information and Communications teams, shaping and influencing the collective strategy based on sound scientific principles, available data, and strategic insights. The Head, Therapeutic Area Lead Rheumatology will represent Medical Affairs leadership in this therapeutic area by identifying and addressing key stakeholders’ needs through data generation, data dissemination, and special initiatives supporting our Rheumatology products.
Specialist 3 - Regulatory Affairs The Fountain Group LLCSpecialist 3 - Regulatory AffairsWest Chester, PA$52–$55 / hourUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices.