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.
NewSenior 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.
NewAssociate 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.
NewSr. Manager, Medical Review - Contract TalentBurst, Inc.Sr. Manager, Medical Review - ContractPlainsboro Township, NJRemote$38–$40 / hourOther notable details about the environment from the hiring manager about this role: Role works cross-functionally with multiple internal stakeholders/partners (i.e. regulatory review, legal, ethics, Medical affairs, commercial). • For designated therapeutic area of responsibility, attends, advises, and approves in review meetings as the lead Medical Reviewer for promotional review.
NewSr Manager, Market Access - US - Medical Device JouléSr Manager, Market Access - US - Medical DeviceBlue Bell, PARemote$145,000–$180,000 / yearLeads all aspects of Market Access actions in North AmericaWorks cross-functionally with Clinical Affairs, Regulatory Affairs, Governmental Affairs, Commercial, Medical Affairs and Regional Marketing colleagues in North America. The ideal candidate has owned the market access role during a product launch in the US market and has worked in close collaboration with other business functions (medical affairs, governmental affairs, legal, regulatory, marketing and sales) in prior roles.
NewDirector, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemotePhiladelphia, PARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 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. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
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.
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.
NewGRA CMC Specialist CSL BehringGRA CMC SpecialistKing of Prussia, PASupport the collaboration with CSL’s Corporate & External Affairs organization to support legislative and statutory initiatives to allow CSL to take an active leadership role in shaping policy and regulatory frameworks that impact the development, registration, and life-cycle management of plasma-derived therapies. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
NewSenior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsPhiladelphia, PAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
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 .
Manager, Regulatory Affairs - Cosmetics (Global) Church & Dwight Co IncManager, Regulatory Affairs - Cosmetics (Global)Princeton, NJ$110,900–$157,900 / yearChurch & Dwight is seeking a Manager, Regulatory Affairs - Cosmetics (Global) to serve as the regulatory subject matter expert for cosmetic products and lead regulatory strategy, risk assessment, and execution to enable compliant new product development (NPD), global market entry, and lifecycle maintenance. This role partners closely with R&D, Marketing, Quality, Legal, Supply Chain, and international subsidiaries/distributors to ensure products meet global regulatory requirements while supporting business growth and on-time product launches.
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.
Group Manager, Regulatory Affairs Globus Medical, Inc.Group Manager, Regulatory AffairsAudubon, PAThe Group Manager, Regulatory Affairs oversees the preparation and submission of regulatory premarket applications, and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. + Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
Regulatory & Clinical Affairs Manager PEAK Technical StaffingRegulatory & Clinical Affairs ManagerPrinceton, NJDesired CharacteristicsCollaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams. Candidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/and https://peaktechnical.com/ca-residents-privacy-rights/
Regulatory & Clinical Affairs Manager PEAK Technical Services Inc.Regulatory & Clinical Affairs ManagerPrinceton, NJ$150,000–$185,000 / yearDesired CharacteristicsCollaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams. To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/ and https://peaktechnical.com/ca-residents-privacy-rights/ .
Principal Regulatory Affairs Project Manager, Medical Devices West Pharmaceutical Services IncPrincipal Regulatory Affairs Project Manager, Medical DevicesExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
Manager, Regulatory Affairs Globus MedicalManager, Regulatory AffairsAudubon, PennsylvaniaGuides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing. Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement.
Senior Manager, Regulatory Affairs West Pharmaceutical Services IncSenior Manager, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. This role serves as a key bridge between regulatory experts, quality, commercial teams, and external clients to enable consistent, high‑quality execution of contracted regulatory deliverables.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsEXTON, PA$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorPennington, NJ$94,556.80–$124,176 / yearSUMMARY: Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
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.
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.
Vice President, Global Regulatory Affairs, Team Lead, Strategy Genmab ASVice President, Global Regulatory Affairs, Team Lead, StrategyPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs, responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of development.
Specialist 3 - Regulatory Affairs Sunrise Systems IncSpecialist 3 - Regulatory AffairsWest Chester, PAFor those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
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.
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.
Vice President, Regulatory Affairs Cabaletta Bio IncVice President, Regulatory AffairsPhiladelphia, PARegulatory Submissions & Compliance Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. Team Leadership Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy.
NewDirector, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionPrinceton, NJ$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
Specialist, Regulatory Affairs Operations Publishing Taiho OncologySpecialist, Regulatory Affairs Operations PublishingPrinceton, NJ$86,700–$102,000 / yearFull timeThe Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with evolving regulations and technologies—including AI—to support drug review, approval and market access while protecting public health. Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsCollegeville, PA$113,850–$189,750 / yearGSK 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.
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.
Specialist 3 - Regulatory Affairs eTeam Inc.Specialist 3 - Regulatory AffairsWest Chester, PA$53–$57.72 / 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.
Specialist 3 - Regulatory Affairs Ampcus IncorporatedSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, 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.
Specialist 3 - Regulatory Affairs LancesoftSpecialist 3 - Regulatory AffairsWest Chester, PA$1Understand, 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.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
North American Regulatory Affairs Specialist International Flavors & Fragrances IncNorth American Regulatory Affairs SpecialistWilmington, DEHealth & Biosciences: Channeling our passion for nature and bioscience into sustainable, life-enhancing technologies that power innovative solutions across healthcare, food, consumer and industrial markets. Prepare and contribute to regulatory submissions, including Generally Recognized as Safe (GRAS), Association of American Feed Control Officials (AAFCO), and Canadian feed (CFIA) approvals.
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.
Associate Director, Global Regulatory Affairs, Advertising & Promotion GenmabAssociate Director, Global Regulatory Affairs, Advertising & PromotionPrinceton, NJFull timeFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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.
Vice President, Regulatory Affairs, CMC Madrigal Pharmaceuticals IncVice President, Regulatory Affairs, CMCConshohocken, PA$315,000–$386,000 / yearPlease know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Specialist 3 - Regulatory Affairs Artech LLCSpecialist 3 - Regulatory AffairsWest Chester, PA$55–$57.30 / 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.
Specialist 3 - Regulatory Affairs Katalyst Healthcares & Life SciencesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, 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.
Specialist 3 - Regulatory Affairs Karwell TechnologiesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, 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.
Regulatory Affairs Supervisor (Pharmaceutical Distribution Ops / Supply Chain) Valley Forge PharmaRegulatory Affairs Supervisor (Pharmaceutical Distribution Ops / Supply Chain)Malvern, PA$50,000EXPERIENCE: -Must have at least 2 years of relevant supervisory or managerial experience in pharmaceutical distribution, wholesale distribution, or pharmacy operations, and the experience must be recent (at least one year within the last three years is stipulated for California's DR requirements). Other responsibilities include comparing identifying information, counts, weighs, or measures items of incoming and outgoing shipments to verify information against bills of lading, invoices orders, and other records.
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.
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.
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.
Senior Manager, Field Medical Affairs-Neurology (mid-Atlantic states) Regeneron Pharmaceuticals IncSenior Manager, Field Medical Affairs-Neurology (mid-Atlantic states)Philadelphia, PA$150,500–$245,500 / yearSupport clinical research activities throughout the life cycle (phase 1-4), as well as Investigator Initiated Studies, focusing on identification of pre-clinical, clinical and post-marketing study investigators/ experts and sites in alignment with Medical Affairs objectives. To be considered a Clinical/Science doctorate Degree required (MD, PharmD, PhD, DNP, DVM) along with a minimum of 3-5 years related work experience preferred (clinical, managed care, or industry experience) including experience as a Medical Science Liaison.
Senior Director, Therapeutic Area Lead, Mood – US Medical Affairs, Neuroscience 6120-Janssen Scientific Affairs Legal EntitySenior Director, Therapeutic Area Lead, Mood – US Medical Affairs, NeuroscienceTitusville, New Jersey$193,000–$333,500 / yearThe Senior Director, Therapeutic Area Lead, Mood, US Medical Affairs, Neuroscience will be a senior strategic decision-maker, balancing scientific rigor, regulatory compliance, patient centricity, and Medical Affairs scientific leadership to generate robust plans for data generation, data dissemination, and critical prelaunch initiatives supporting future indications. Reporting to the Vice President of US Medical Affairs, this senior leader will be accountable for the execution and attainment of key medical objectives in compliant alignment with the business strategy and lead the team to deliver high-quality communications regarding the science and clinical applications of our products and/or the disease states to external stakeholders on a regional, national, and international level.