- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and ... and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global ... submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by...PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in … more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC post ... regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Medical Director, Medical Affairs - Dermatology role will be responsible for supporting the product through ... hidradenitis suppurativa (HS) via leadership, mentorship, and execution of the Medical Affairs strategic vision. This position will report directly to the Executive… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director, Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The individual ... collaboration skills and will work closely with a global regulatory lead (s) to help develop and implement... science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions With direction from ... lead the implementation of, process/system improvements related to regulatory submissions (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats). May… more
- Genmab (NJ)
- …setting.The Director, HEOL Team Lead is part of the US Field Medical Affairs leadership team responsible for the execution of the US Medical Affairs strategy ... insights and needs for materials related to field engagementCooperate with Field Medical Affairs leadership team to co- lead and manage change initiatives in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... patients than ever before. The Position The Brand Strategy Lead is pivotal in developing brand level objectives and...drive market share and revenue growth. Partner with legal, regulatory , and medical affairs for timely review… more
- Merck & Co. (North Wales, PA)
- …knowledge of best practices in those areasU.S./Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory AffairsPreferred Skills:… more
- Merck & Co. (Rahway, NJ)
- …of experience in global patient advocacy and engagement activitiesUS/global experience in regulatory affairs , medical and scientific affairs , and ... Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) organization,… more
- BeOne Medicines (Emeryville, CA)
- …required; advanced degree preferred + Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience ... **General Description:** The Director, Regulatory Affairs will be responsible for...management, people development, and performance management as well as support/ lead development and implementation of department policies. **Essential Functions… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …medical/clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2)… more
- Merck & Co. (Rahway, NJ)
- …communications.Stakeholder Collaboration: Work closely with cross-functional teams (medical affairs , communications, regulatory , GEMs etc.) to ensure ... Engagement works closely with the Scientific Patient Engagement & Advocacy Lead and is responsible for the strategic planning, coordination, operational excellence… more
- Insmed Incorporated (NJ)
- …will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program ... with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company's small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... messaging, and go-to-market frameworks tailored to HCPs treating fibrosing ILDs. Lead campaign development to engage pulmonologists, ILD specialists, and community… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… more
- Syner-G BioPharma Group (Boston, MA)
- …and energy management.Collaborate with internal stakeholders including EHS, IT, and Regulatory Affairs to support compliance and operational goals.Develop and ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- Merck & Co. (North Wales, PA)
- …the Vice President & leader of the Respiratory Business Unit will lead an organization of ~15 employees.- Primary Responsibilities:Strategic Planning: Develop and ... within allocated resources and profitability targets. Team Leadership: Build and lead a high-performing team, providing clear direction, guidance, and coaching to… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... the primary toxicology subject matter expert for interactions with regulatory agencies (FDA, EMA, etc.); support or lead... regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND,… more
