- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Bridgewater, NJ)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs ...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning… more
- Merck (Rahway, NJ)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** The Director , Regulatory Affairs Liaison,...our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within… more
- Bausch Health (Bridgewater, NJ)
- …regulatory agency guidance. **KEY ACTIVITIES/RESPONSIBILITIES:** + Manages or represents Regulatory Affairs on the promotional review committees for ... Bausch Health is a global company that develops, manufactures, and markets a...new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... for the United States and the Americas and supporting global needs as required. The RA Associate Director...for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Bausch Health is a global company that develops, manufactures, and markets a...and the ability to see business drivers outside of regulatory affairs + Working knowledge of the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, ... side) + **CDx RA Policy and Intelligence:** Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Pfizer (New York, NY)
- …, Internal Medicine, GMA (CV/EB) is an integral member of the Internal Medicine Global Medical Affairs Team. The Director combines the medical expertise ... medical professionalism with honor and integrity. **ROLE RESPONSIBILITIES** The Director , Internal Medicine, GMA (CV/EB) serves as the technical expert… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device ... aspects of registration activities with a working knowledge of regulatory affairs , in the development of the...effectively in a multidisciplinary team. + Experience working with global regulatory agencies. + Demonstrated business acumen… more
- Pfizer (New York, NY)
- …and understand the point of view of patients and HCPs. Working closely with Global Medical Affairs and cross-functional colleagues, s/he ensures that the US ... Job Description **ROLE SUMMARY** The Senior Medical Director will be responsible for leading several US...tactics and ensure the delivery of these plans + Global Medical Affairs Team Meetings: + Participate,… more
- IFF (Hazlet, NJ)
- … Affairs -North America (Hybrid) It's an exciting time to be part of IFF's Global Regulatory Affairs . This hybrid role requires presence in the office ... and customers. This role will be reporting to the Director of Regulatory Affairs , Americas....systems and supporting IFF product innovations). We are a global leader in taste, scent and nutrition, offering our… more
- New York State Energy Research and Development Aut (New York, NY)
- …and renewable energy. Job Overview The Vice President, Legal and Regulatory Affairs will report directly to NYGB's Managing Director , Legal and Regulatory ... York is leading the nation in the fight on global climate change and the transition to a clean...firms; and + Consulting and collaborating with NYGB's Managing Director , Legal and Regulatory Affairs … more
- Pfizer (New York, NY)
- …medical affairs and cross-functional US Vyndaqel/Vyndamax team(s). The medical director will support key internal and external medical initiatives such as ... **ROLE SUMMARY** The Medical Director will provide leadership and expertise in Transthyretin...patients and physicians point of view. Works closely with Global Medical Affairs and cross-functional colleagues to… more
- Bausch Health (Bridgewater, NJ)
- …effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education ... with outstanding collaboration and teamwork with key partners such as, Medical Affairs , Marketing, Sales, Compliance, Quality, KOLs, etc. This role is responsible… more
- Colgate-Palmolive (New York, NY)
- …lives by their values, then give your career a reason to smile and join our global team! The Director of North America (NA) Consumer Care & Experience (CCE) ... consumer/customer service that meets corporate and local standards with regulatory compliance, cost efficiency, and achievement of key performance indicators… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners ... with the Global Regulatory Lead (GRL) on ...the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription… more