- Novo Nordisk (Princeton, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate 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… 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 ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned,… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo...rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …of patients with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and ... Director , Strategy Lead of PAQ Virology. The Associate Director of Medical Affairs ...the US healthcare landscape. + Solid working knowledge of regulatory and compliance environment. + Effective organizational, project planning,… more
- Novo Nordisk (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and maintains constructive and… more
- Sanofi Group (Bridgewater, NJ)
- **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and ... the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global R&D. **Position… more
- Novo Nordisk (Princeton, NJ)
- …clinical development and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development ... teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of...plans, study designs, and regulatory submissions. Relationships The Associate Director… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Associate Director , New Product Strategy - Parsippany, NJ Date: May 13, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... our in-house development and 3rd party partners. As an Associate Director , New Product Strategy your challenge...coordination with key stakeholders in Generic R&D, Operations, Legal Affairs , Regulatory Affairs , Quality Management,… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Digital Medical Capabilities-Titusville, NJ - 2406186911W **Description** At Johnson & Johnson, we believe health is everything. Our strength ... seeking a highly motivated and experienced individual for the position of Associate Director , Digital Medical Capabilities. The successful candidate will play… more
- Amicus Therapeutics (Princeton, NJ)
- …with Technical Operations, Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is ... Associate Director , External Quality Lead (Small...Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance of outsourced… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Sanofi Group (Bridgewater, NJ)
- About the job - US Medical Associate Director , Respiratory **Our Team:** This position will report into the US Medical Immunology team which is a segment of the ... Medical Affairs Specialty Care organization. Our Medical Affairs ...serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support… more
- Bristol Myers Squibb (Princeton, NJ)
- …to the Director , Worldwide Immunology & Neuroscience Communications, Corporate Affairs . The Associate Director , Worldwide Immunology Communications, ... policy and reputational goals. + Lead communication planning for regulatory submissions and product approvals; partner closely with Development Communications… more
- Ascendis Pharma (Princeton, NJ)
- …grow and develop their skills. Ascendis Pharma is looking to hire an experienced Associate Director , Market Access, Payor and Channel Marketing to join our team. ... such as Pricing, Contracting & Distribution (PCD), Brand Marketing, Medical Affairs , Finance, Legal, other Market Access colleagues, external customers and agency… more