- Novo Nordisk (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Bristol Myers Squibb (Madison, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Merck (Rahway, NJ)
- … Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... business process management and continuous improvement. + Establish and lead assigned domain Global Process Control Boards...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …interacts with other therapeutic area leaders and joint Alliance partners. **Responsibilities** + Lead a multidisciplinary Global Regulatory Team (GRT) to ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Summary:** The Director of Pricing and Market Access Strategy Lead will be responsible for the overall Global Market Access (GMAx) ... medical, regulatory , clinical, advocacy, policy, business Insights & analytics global leads), and with the relevant individual market stakeholders across the… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Taiho Oncology (Princeton, NJ)
- …Summary: Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, ... Associate Director , Regulatory Affairs Operations Pleasanton, CA,...contract review and negotiation. + Strong working knowledge of global regulatory requirements and submission processes. +… more
- Bristol Myers Squibb (Madison, NJ)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… 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 ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… 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 ... process improvements or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance on new marketing… more
- Bristol Myers Squibb (Summit, NJ)
- …applications while upholding regulatory requirements. + Extensive knowledge of applicable global regulatory standards which apply to both ATMPs and sterility ... lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: Seattle, WA, Devens,… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for ... the management of global regulatory leads with product and disease...pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in at least… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Compliance & Ethics, Global R&D and Medical Affairs Date: Sep 6, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... people to make a difference with. **The opportunity** The Director Compliance & Ethics, Global R&D and...will leverage in-depth expertise and knowledge of the industry's legal/ regulatory environment in order to provide clear, concise and… more
- Sanofi Group (Bridgewater, NJ)
- …gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of ... curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to...direction of the Global Respiratory and Gastroenterology Global Medical Lead This role will closely… more
- J&J Family of Companies (Raritan, NJ)
- …**Description** Johnson & Johnson is currently recruiting for a Director , Biosurgery Global Supply Chain Planning Lead . This position can be based in ... Learn more at https://www.jnj.com/. The Director Biosurgery Global Supply Chain Planning Lead is responsible...with deep regional/market insights * Understanding of statutory and regulatory requirements (eg, GMP, GDP practices ) * Driving… more
- Sanofi Group (Bridgewater, NJ)
- …for chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** + The Global Medical Director of Rheumatology, reports to the ... function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to...works under the direction of the Dermatology and Rheumatology Global Medical Lead . + This role will… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal...and external to GPS including senior management. The GPS Director joins Regeneron's industry leading scientific organization, and has… more