- Sanofi Group (Bridgewater, NJ)
- …was possible. Ready to get started? **Main responsibilities:** + As the Global Regulatory Affairs CMC Lead for Influenza, you will be responsible for ... biological entities, and/or vaccine products) in collaboration with other parts of Global Regulatory Affairs . + Interpret global regulations &… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the ... progress and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for directing and managing the… more
- Sanofi Group (Bridgewater, NJ)
- …limits of what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the ... **Job title: Global Regulatory Lead ** +...**Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global… more
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Director, Global Regulatory Affairs , Precision Medicine you will develop and ... will need to work closely with the Vice President, Global Regulatory Affairs Oncology and...and presents to senior leadership as required. + Develops, lead , and communicate a business plan to and implements… more
- Merck (Rahway, NJ)
- **Job Description** The GRACS Global Process Model Lead is primarily accountable and responsible for the overall governance and leadership of the GRACS Global ... GRACS Global Process Leads, leadership for the Global Process Lead Network, as well as... Model. Champions continuous improvement to meet the evolving regulatory environment. + Provides overall leadership for the GRACS… more
- Merck (Rahway, NJ)
- … Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- 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...or More Years of proven experience in a regional regulatory lead role + 7 or More… 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
- J&J Family of Companies (Raritan, NJ)
- …recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs , supporting programs in the Immunology Therapeutic ... Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson...Johnson & Johnson, we all belong. The Associate Director, Regulatory Affairs will be responsible for the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and procedural cross-functional teams. + ... alignment with overall development plan. + Is assigned as lead contact with FDA and Health Canada or delegated...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Merck (Rahway, NJ)
- **Job Description** The Senior Specialist, Global Regulatory Affairs and Clinical Safety (GRACS) Standards & Execution is a member of Business Continuity, ... process operating model. Under the guidance of the Director, Standards & Execution Lead , the Standards & Execution Sr. Specialist is responsible for the planning and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and external regulatory agencies. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy ... Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and...partners, stakeholders, and teams. You will oversee or otherwise lead impact assessments on major global labeling… more
- Merck (Rahway, NJ)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Regulatory Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. ... for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global ...Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project teams… more
- Merck (Rahway, NJ)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead , is responsible for development and ... for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Mondelez International (East Hanover, NJ)
- …job application process may contact ### for assistance. **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality, Safety and Compliance ... It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.**...The Sr. Scientist II will u execute the scientific affairs strategy for your respective categories and geographical area… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager** **Position Summary** Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ... aspects and climate that would affect proposed activities. The Regulatory Affairs Project Manager combines knowledge of...every patient, consumer, and Catalent employee.** **The Role** + Lead the development of regulatory strategy for… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- … compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible for ... it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading the… more