- Formation Bio (New York, NY)
- …preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations) to ensure alignment on quality ... to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA..., GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting as… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs , Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs , Global Patient Safety, and Development… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the Job** Are you ready to ... you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion...and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance… 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 ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... filings but could include CMC issues. With regard to these matters, the Senior Director will provide strategic as well as regulatory leadership on the project… more
- BlackRock (New York, NY)
- …retirement, energy security, financial technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government ... policymakers around the world on financial markets policy. Since 2009, the Government Affairs & Public Policy team has steadily established the firm as a respected… more
- City of New York (New York, NY)
- … Director of OCMH and executive staff to set and execute the External Affairs strategy for the office. Additionally, the Deputy Executive Director will ... Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the...by directing and supporting the development of OCMH's media strategy to ensure clear and compelling updates to the… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more
- System One (Florham Park, NJ)
- Job Title: Director , US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), ... Regulatory Affairs (Senior Director ) in...Regulatory Affairs (Senior ...clinical development (as needed) + Contributions to/ finalization of regulatory strategy plans for antimicrobials in development… more
- Bristol Myers Squibb (Madison, NJ)
- …with cross-functional teams to ensure evidence generation efforts support regulatory submissions, reimbursement decisions, and market access strategy . ... . **Position Summary:** We are seeking a dynamic and visionary Worldwide Medical Affairs Disease Area Head (WW-DAH) to oversee our Oncology Worldwide GI, GU Cancers… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …you if you:** * Want a highly visible position with frequent interactions with Regulatory Affairs , Legal and Commercial. * Have outstanding work ethic and ... As a Medical Director in Medical Affairs you will support the development of our strategy , planning & execution of medical affairs activities. This role… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …you if you:** * Want a highly visible position with frequent interactions with Regulatory Affairs , Clinical, Legal and Commercial. * Have outstanding work ethic ... As an Associate Medical Director of Medical Affairs you will...Affairs you will support the our Ophthalmology medical strategy , planning & execution of these activities. This role… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs . The incumbent will lead a group ... regulatory strategies for product development. This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic Area (TA)… more
- Sanofi Group (Morristown, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job title** : Global Medical Director , Evidence Generation - Insights and Strategy...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Sanofi Group (Morristown, NJ)
- **Sr. Director , Global Switch Medical Strategy ** + _Location: Morristown, NJ /Hybrid_ **_About the job_** Are you ready to shape the future of Consumer Health? ... + **Cross-Functional Collaboration** - Collaborate with internal stakeholders (R&D, regulatory , safety, medical affairs , commercial) to drive switch-related… more
- Danaher Corporation (New York, NY)
- …in working at the pace of change to improve patient lives! The Senior Director , Worldwide Market Access Strategy , Oncology and Hematology will lead Market Access ... the cross-functional team (Marketing, Product Management, Commercial, Medical & Scientific Affairs , Regulatory , Strategic Business Planning, other Value and… more
- Danaher Corporation (New York, NY)
- …Managers towards it; build and maintain strong relationships with R&D, Clinical & Regulatory Affairs , Marketing, Operations, and Quality + Own & improve Beckman ... lives with diagnostic tools that address the world's biggest health challenges. The Director , Product Portfolio Strategy and Enablement role is responsible for… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research ... **Job title** : GRA Device Lead (Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About...accountable to develop and maintain device aspects of project regulatory strategy documents. The incumbent will provide… more
- Bristol Myers Squibb (Summit, NJ)
- …are completed + Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be mainly… more
- AbbVie (Florham Park, NJ)
- …clinical development projects. A visible and collaborative role, the Associate Director / Director works in partnership with clinical and regulatory experts to ... own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission....Statistical programmers + Data science experts + Global Medical Affairs experts + Regulatory experts *Job title… more
