- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies, non-interventional studies, Compassionate Use or Managed Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality ... diseases and immune disorders. Job Summary: Reporting to the Sr . Director , Medical Affairs QA,...the Quality organization at senior levels. The Director plays a pivotal role in regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Merck & Co. (Rahway, NJ)
- …innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also ... manage significant cross-modality projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays a critical role in driving… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... radically changes the way we approach serious diseases. --The Senior Director will report to an Associate...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities ... execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality… more
- Ascendis Pharma (Princeton, NJ)
- …As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. This position will ... as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and...without managerial oversight, as appropriate. + Operates independently, with recognition of when to consult departmental senior … more
- Vistra (Cleveland, OH)
- …that are currently available and apply online. **Job Summary** The Director , Regulatory Affairs is a senior leadership role responsible for overseeing ... upgrades, or decommissioning. + Lead, mentor, and develop a team of regulatory affairs professionals, fostering a culture of accountability, compliance, and… more
- Sumitomo Pharma (Tallahassee, FL)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...Comfortable presenting to all levels of the organization including Senior Management. + High degree of organizational awareness, ability… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …to learn, grow and become your best self. Become a **maker of possible** with us. The Sr . Director , Regulatory Affairs is the ranking Regulatory ... with RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... is responsible to communicate these updates to the identified Sr . Management on a timely basis including R&D for...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
- Stryker (San Jose, CA)
- The ** Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** ... partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product… more
- Actalent (St. Paul, MN)
- Director of Regulatory Affairs Structural Heart | Medical Device Relocation Offered We are seeking an experienced Director of Regulatory Affairs ... as a strategic advisor to the executive team and develop a high-performing regulatory affairs team to support company objectives across product lifecycles.… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Boehringer Ingelheim (Athens, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , US Regulatory Affairs Pharmaceuticals leads the US ... Management of existing products in accordance with company priorities and governance. The Director , US Regulatory Affairs Pharmaceuticals is a key interface… more
- Penn Medicine (Philadelphia, PA)
- …Street, Philadelphia, PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- Candela Corporation (Marlborough, MA)
- ** Director , Global Regulatory Affairs ** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** ... and audit/inspection readiness. + Global accountability to establish/maintain a high-performance Regulatory Affairs team. + Actively support New Product… more
Related Job Searches:
Affairs,
Director,
Director Regulatory Affairs,
Director/sr Regulatory,
Regulatory,
Regulatory Affairs,
Regulatory Director,
Sr,
Sr Director