Director, Regulatory Affairs - Development Strategy Insmed IncDirector, Regulatory Affairs - Development StrategyBridgewater, NJRemote$185,000–$252,500 / yearReporting to the Executive Director, Regulatory Affairs, you'll provide strategic and operational regulatory leadership to support both business development and early-stage drug development programs and be responsible for strategic evaluation of regulatory risks and opportunities for external assets, including assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will work cross-functionally to enable informed investment decisions and efficient advancement of development programs and develop regulatory strategy for selected drug candidates and provide regulatory input to global cross-functional project teams throughout product development and submission activities and will serve as the global or regional regulatory lead on the projects.
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 is advancing its lead anti-IL-1 monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1–4% of the population globally.
Legal Counsel Corporate And Regulatory Affairs - Transactions Atlantic Health System IncLegal Counsel Corporate And Regulatory Affairs - TransactionsMorristown, NJServe as a key legal resource on healthcare regulatory matters, including fraud and abuse laws (Stark Law and Anti-Kickback Statute), HIPAA, EMTALA, Medicare and Medicaid requirements, licensure, reimbursement, corporate governance, tax-exempt organization issues, pay-to-play requirements, and other federal and state healthcare regulations. Build strong working relationships with leaders in Finance, Strategy, Compliance, Privacy, Risk Management, Internal Audit, Human Resources, Supply Chain, Information Technology, Clinical Operations, and other functional areas to facilitate sound business decisions and effective risk management.
Scientist I - Regulatory Affairs The Campbell's CoScientist I - Regulatory AffairsCamden, NJ$68,700–$94,500 / yearOur portfolio includes the iconic Campbell's brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao's Homemade, Snack Factory, Snyder's of Hanover. Under general supervision, Regulatory Affairs Scientist I will support food product compliance by helping to ensure ingredients, formulas/recipes, labels, claims, and supporting documentation meet applicable food regulations, internal policies and customer requirements.
Associate Director, Regulatory Affairs - CMC PTC TherapeuticsAssociate Director, Regulatory Affairs - CMCWarren, NJ$169,100–$212,800 / yearLeads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements. Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
NewQuality, Regulatory, & External Affairs Foundational Learning Experience Program (QR&E FLEX) F. Hoffmann-La Roche LtdQuality, Regulatory, & External Affairs Foundational Learning Experience Program (QR&E FLEX)branchburg, NJ$65,000–$72,000 / yearAs a global leader in healthcare, Roche Diagnostics offers a broad portfolio of tools that help healthcare providers in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes and other medical conditions, such as fertility, blood coagulation, and various forms of cancer. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Assoc. Dir, Regulatory Affairs-CMC Merck & Co IncAssoc. Dir, Regulatory Affairs-CMCRahway, NJ$142,400–$224,100 / yearRequired Skills: Change Management, Collaboration, Electronic Common Technical Document (eCTD), Emerging Technologies, Interpersonal Relationships, Liaison Work, Manufacturing Processes, Multitasking, Project Leadership, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Partnerships. Mentorship & Community Building: Propose, lead, and mentor digital project teams-including guiding GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement-while fostering collaboration across the broader AI/Digital Enablement community.
Medical and Regulatory Affairs - Medical Scientist TechDigital CorporationMedical and Regulatory Affairs - Medical ScientistTrenton, NJUnder the direct mentorship of the GI Tumor Leads, develop understanding of the assigned tumors and medical strategies, provide strategic input to a broad range of stakeholders, and facilitate strategic alignment. The primary responsibility of Medical Scientist is to support GI medical and tumor leads in translating medical strategies into tactical plans and leading the execution of these plans for assigned tumor(s).
NewQuality Analyst CYNET SYSTEMSQuality AnalystTITUSVILLE, NJ$34–$39 / hourTemporaryContractorPart timeAs a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
Associate Director Medical Affairs, Endocrine Medical Sciences - Job ID: 1965B Ascendis PharmaAssociate Director Medical Affairs, Endocrine Medical Sciences - Job ID: 1965BPrinceton, NJ$190,000–$205,000 / yearWork with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to support the US Medical Director in successful management of Medical Affairs projects, and provide medical perspective and scientific guidance within cross-functional discussions to support informed decision-making. Build and manage relationships and strategic partnerships, and interact regularly with Key Opinion Leaders/Influencers, clinical investigators, healthcare customers, strategic alliance partners, vendors, professional societies and organizations, and patient advocacy groups, and synthesize external insights to inform internal cross-functional discussions and decision-making.
Associate Director, Training & Education-Medical Affairs Summit Therapeutics plcAssociate Director, Training & Education-Medical AffairsPrinceton, NJExperience, Education and Specialized Knowledge and Skills: Advanced degree (PharmD, PhD, MD, or equivalent) in life sciences or healthcare-related field with a minimum of 3+ years of Medical Affairs & training related experience or 5+ years of life sciences related experience. Collaborate with cross-functional teams (Medical Communications, Clinical Development, Health Economics and Outcome Research, Regulatory, Commercial, Compliance, Patient Advocacy, and Medical Information) to ensure training content reflects current data and strategic priorities.
NewAssociate Director, Training & Education-Medical Affairs Summit TherapeuticsAssociate Director, Training & Education-Medical AffairsPrinceton, New Jersey$174,000–$204,000 / yearHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Collaborate with cross-functional teams (Medical Communications, Clinical Development, Health Economics and Outcome Research, Regulatory, Commercial, Compliance, Patient Advocacy, and Medical Information) to ensure training content reflects current data and strategic priorities.
Senior Director, Managed Access Programs, Medical Evidence Generation (Worldwide Medical Affairs) Bristol Myers SquibbSenior Director, Managed Access Programs, Medical Evidence Generation (Worldwide Medical Affairs)Princeton, NJ$229,380–$277,956 / yearThe MAPs Lead will provide strategic input, oversight, and coordination to ensure a streamlined and efficient approach to managed access and ensure equity, sustainability, scalability, and appropriate data capture across their respective disease areas. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Associate Director, Global Medical Affairs Execution 6085-Janssen Global Services Legal EntityAssociate Director, Global Medical Affairs ExecutionRaritan, New JerseyAnalytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization of Tasks, Product Strategies, Scientific Research, Strategic Thinking, Team Management . Responsibilities : Leading the development and implementation of Global Medical Affairs strategic business priorities, partnering cross-functionally and cross-regionally with functional business leaders to ensure alignment and sustainable implementation.
Medical Director, Medical Affairs, ALS Shionogi Inc.Medical Director, Medical Affairs, ALSFlorham Park, New Jersey$230,000–$280,000 / yearDevelop and maintain excellent working relationships with both US and global Clinical Development, Marketing, and Regulatory functions, ensuring seamless communications and provision of up to date scientifically accurate clinical information to external and internal sources. Overview: The Medical Director will be responsible for developing and overseeing the execution of Medical Affairs programs in the US that support pre-approval, marketed, and late development products and compounds with a focus on ALS, rare disease.
Chancellor, Rutgers Health & Executive Vice President for Health Affairs and Chief Academic Officer, RWJBarnabas Health Rutgers The State University of New JerseyChancellor, Rutgers Health & Executive Vice President for Health Affairs and Chief Academic Officer, RWJBarnabas HealthNewark, NJ1 in New Jersey, # 11 in the nation, Public Health-Environmental Health Sciences # 1 in New Jersey, # 15 in the nation, Nursing-Midwifery # 1 in New Jersey, # 16 in the nation, Public Health # 1 in New Jersey, # 17 in the nation, Nursing-Master's # 1 in New Jersey, # 17 in the nation: Public Health-Social and Behavioral Sciences # 1 in New Jersey, # 19 in the nation, Public Health-Epidemiology # 1 in New Jersey, # 22 in the nation, Public Health-Biostatistics # 1 in New Jersey, # 24 in the nation, Pharmacy # 1 in New Jersey, # 25 in the nation, Health Policy and Management # 1 in New Jersey, # 28 in the nation, Healthcare Management # 1 in New Jersey, # 33 in the nation, Physical Therapy # 1 in New Jersey, # 36 in the nation, Rehabilitation Counseling #1 in the Nation - Liver Transplant Survival, led by Rutgers New Jersey Medical School (at University Hospital) Rutgers School of Nursing: Eight-consecutive-year winner of the Best Schools for Men in Nursing award New Jersey's only dental school (Rutgers School of Dental Medicine) Posting Summary Position Summary The Chancellor of Rutgers Health and Executive Vice President for Health Affairs at Rutgers University and Chief Academic Officer at RWJBarnabas Health (The Chancellor) is an integral member of the University's senior executive leadership team and serves as the chief academic and research officer for Rutgers' health enterprise. The eight schools of Rutgers Health comprise New Jersey's largest and most influential constellation of academic institutions devoted to the education of the full complement of health care professionals: Ernest Mario School of Pharmacy Robert Wood Johnson Medical School (RWJMS) School of Graduate Studies School of Nursing New Jersey Medical School Rutgers School of Dental Medicine School of Health Professions School of Public Health These research centers and institutes contribute to Rutgers Health's mission: Brain Health Institute Center for Advanced Biotechnology and Medicine Center for COVID-19 Response and Pandemic Preparedness Center for Tobacco Studies Rutgers Institute for Translational Medicine and Science Environmental and Occupational Health Sciences Institute Institute for Health, Health Care Policy, and Aging Research Rutgers Cancer Institute of New Jersey University Behavioral Health Care Education & Training Rutgers Health provides one of the nation's most comprehensive academic health education environments, offering a full continuum of undergraduate, graduate, and professional training across its eight health-related schools.
Associate Director, Global Medical Affairs Publication Operations 6085-Janssen Global Services Legal EntityAssociate Director, Global Medical Affairs Publication OperationsRaritan, New JerseyFamiliar with the overall publication plan for product(s) and proactively fulfills Pub Ops’ role in generating assigned publications, including assigning medical writers and providing editing and project management to efficiently deliver high-quality publications to author teams. · Please use the following language: • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Medical Director, Medical Affairs, ALS Shionogi & Co LtdMedical Director, Medical Affairs, ALSFlorham Park, NJ$230,000–$280,000 / yearDevelop and maintain excellent working relationships with both US and global Clinical Development, Marketing, and Regulatory functions, ensuring seamless communications and provision of up to date scientifically accurate clinical information to external and internal sources. In collaboration with the VP Medical Affairs and Executive Medical Director, propose strategic medical affairs plans to support programs in the US for pre-approval, marketed, and late development products and compounds with a focus on rare diseases.
Manager, Global Medical Affairs Operations - Contract Summit Therapeutics IncManager, Global Medical Affairs Operations - ContractPrinceton, NJHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. The Manager will support cross-functional coordination, documentation, meeting logistics, and operational reporting across activities such as congress planning, advisory boards, patient advocacy initiatives, and other key Global Medical Affairs projects.
NewAssociate Director, Project Management - Medical Affairs (Princeton, NJ or Palo Alto, CA) Summit TherapeuticsAssociate Director, Project Management - Medical Affairs (Princeton, NJ or Palo Alto, CA)Princeton, New JerseyHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. The role will serve as a central point of contact for operational planning, delivery, and governance of critical Medical Affairs projects—spanning scientific communications, congress strategy, advisory boards, medical education, and post-marketing data generation supporting launch preparation.