- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health outcomes. Are you ready to realize your potential? The Position The Regional Lead of State Government Affairs sits within the State Government Affairs ... in several states in the assigned region. Relationships Reports to the Team Lead Government Affairs , State. External relationships include but are not limited… 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
- Post Holdings Inc. (Lakeville, MN)
- …and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs ** , where you'll lead a talented team and shape the ... high-impact leadership role that blends strategic oversight with hands-on regulatory expertise. **What You'll Do** + ** Lead ...years of experience in pet food, food science, or regulatory affairs . + Proven leadership experience managing… 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
- 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
- Parexel (Trenton, NJ)
- …to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, ... **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a...a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional… 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
- Merck & Co. (Boston, MA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… 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
- 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
- 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
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as ... you will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with… more
