- Insmed Incorporated (San Diego, CA)
- …service providers, ensure high quality, on-time submission activities related to regulatory file maintenance eg IND/CTA, information amendments, SAE reports, ... and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional… more
- Genmab (NJ)
- …and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/ filing activitiesExperience:Master's or PhD in a statistical ... like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as… more
- Tris Pharma (Monmouth Junction, NJ)
- …and clinical development plans from first-in-human through late phase trials and regulatory filing . The role requires strong expertise in pharmacokinetics, ... success.We have an opening in our Monmouth Junction, NJ Facility for a Director , Clinical Pharmacology. The Director , Clinical Pharmacology is responsible for… more
- Merck & Co. (Rahway, NJ)
- …VCM Product Leader will be responsible for supply chain design, global filing and launch strategy, long-range demand vs capacity planning, integrated risk ... including identification & prioritization of mitigation strategies. Lead Global Filing and Launch (GFLS) strategy development to gain cross-divisional alignment… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:Reporting to the Director of Technical Operations, Project Management this position will be responsible for ... Research into Technical Operations and through to readiness for registration and filing .Ensure all functions are engaged and aligned with project goals including… more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion will be an internal expert ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, Advertising and Promotion is responsible for… more
- Fujifilm (Research Triangle Park, NC)
- …improvement initiatives + Manages regulatory activities such as Site Master File , 3.2.A.1, Drug Master Files, and customer filing + Administers company ... **Position Overview** The Director , Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...and mentor regulatory professionals. **Premarket:** + Approve regulatory filing strategies based on proposed preclinical,… more
- Stryker (Tempe, AZ)
- …use/special access approvals based upon patient needs and risk assessment + Approves regulatory filing strategies for complex and/or critical products based upon ... The ** Director , Regulatory Affairs** is a key strategist, responsible for developing and executing the global regulatory strategy for **Stryker… more
- Travelers Insurance Company (Hartford, CT)
- …strategies for upholding standards and educating staff on proactive compliance measures. As a Director , Regulatory & Filing , you will direct and manage the ... - $184,200.00 **Target Openings** 1 **What Is the Opportunity?** The Regulatory & Filing team is dedicated to ensuring Travelers' products and practices adhere… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Virology Global Regulatory Affairs, you will develop and execute ... plan. + Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy is ... approval for product(s) in the Oncology therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic… more
- New York State Civil Service (New York, NY)
- NY HELP No Agency Financial Services, Department of Title Assistant Chief Regulatory Unit ( Director Financial Services Programs 2, SG-33) Occupational Category ... of Financial Services is seeking candidates for the position of Assistant Chief Regulatory Unit in the Health Bureau. Duties include, but are not limited to,… more
- American Electric Power (Columbus, OH)
- …leadership and strategic direction and implements change in the areas of regulatory policy, filing requirements, and tariff and contract administration. Plans, ... strategic direction and implements change in the areas of regulatory policy, filing requirements, and tariff and contract administration. Plans, organizes and… more
- Charles River Laboratories (Wayne, PA)
- …or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the Charles ... are accurate, thorough, timely, and provide the correct interpretation of regulatory requirements and corporate policies. ⦁ Maintain a close working relationship… more
- ThermoFisher Scientific (Wilmington, NC)
- …guidance in all areas of the business, from pre-approval activities, to filing , distribution, and post-approval regulatory activities, among others. **The ... role will be an essential part of the global regulatory team. This role serves as a close business...activities globally + Support in identifying the organization's suitable filing approach, and work together with various subject areas… more
- American Water (Sacramento, CA)
- …leadership team. Oversees the planning and execution of state rate and regulatory strategy for California and Hawaii with joint accountability for meeting business ... rate cases, rate mechanism compliance filings and other key rate and regulatory matters are executed effectively to achieve business objectives of California and… more
- Bristol Myers Squibb (Princeton, NJ)
- …or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global ... in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** The… more
- Treasury, Departmental Offices (Washington, DC)
- … for Compliance, OFAC's Assistant Director for Policy, and OFAC's Assistant Director for Regulatory Affairs, and other relevant OFAC personnel on all ... - Office of Foreign Assets Control. As a Assistant Director - Licensing, you will be Responsibilities As a...and use a Government-issued charge card for business-related travel. File a Confidential Financial Disclosure Report within 30 days… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …matter expert in regulatory affairs. Your expertise spans global regulatory filing strategies, WHO prequalification, and LMIC registration pathways for ... by guiding global regulatory strategies, addressing complex regulatory questions, and ensuring filing strategies are...Senior Program Officer, you will report to the Deputy Director of Regulatory Strategy and Product Support.… more
