- 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
- 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)
- …with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA ... Experience in the pharmaceutical industry + 7 or More Years with direct regulatory affairs experience + Managerial experience preferred + Experience with ex-US… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Catalent Pharma Solutions (Somerset, NJ)
- …Catalent employee. The primary duty of the **Associate Director , Regulatory Affairs ** is to support regulatory strategy for product development and ... **Associate Director , Regulatory Affairs ** **Position...in conjunction with clients in support of meetings with regulatory authorities + Provide regulatory strategy… more
- Merck (Rahway, NJ)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for ... the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more of our Company's… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… 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 ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...or More Years relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the clinical ... Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy /Portfolio Management, Global Device… more
- Novo Nordisk (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific resources, communications, and training initiatives for the medical affairs team + Serve on Clinical Trial Strategy… more
- IFF (Hazlet, NJ)
- …scent design managers, account teams and customers. This role will be reporting to the Director of Regulatory Affairs , Americas. About You: To be successful ... Manager, Regulatory Affairs - North America (Hybrid) Apply...sustainability and product claims. + Articulate and execute GRA strategy by giving internal and external presentations. + Actively… 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 ... LOIs + Working with NYGB senior management and its Strategy and Communications team to manage applications for federal...firms; and + Consulting and collaborating with NYGB's Managing Director , Legal and Regulatory Affairs … more
- IFF (Hazlet, NJ)
- …scent design managers, account teams and customers. This role will be reporting to the Director of Regulatory Affairs , Americas. About You: To be successful ... Associate Manager, Regulatory Affairs (Hybrid) Apply now "...sustainability and product claims + Articulate and execute GRA strategy by giving internal and external presentations + Participating… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and ... and immune disorders. **Summary** With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states… more
- Novo Nordisk (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents for inclusion in these applications + Review of regulatory strategy documents; eg, provides supervisor with… more
- Bausch Health (Bridgewater, NJ)
- …and effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education ... strategy , developing & nurturing relationships with internal & external...collaboration and teamwork with key partners such as, Medical Affairs , Marketing, Sales, Compliance, Quality, KOLs, etc. This role… more
- Colgate-Palmolive (New York, NY)
- …then give your career a reason to smile and join our global team! The Director of North America (NA) Consumer Care & Experience (CCE) Operations at Colgate Palmolive ... consumer/customer service that meets corporate and local standards with regulatory compliance, cost efficiency, and achievement of key performance indicators… more
- Ascendis Pharma (Princeton, NJ)
- …the US Medical Directors to drive the development and execution of the US Medical Affairs strategy and tactics in alignment with key stakeholders. . Develops and ... assets at Ascendis Pharma. In addition to leading the strategy and execution of phase IV (post-marketing, Registry, Early...Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs… more