- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- BeOne Medicines (Emeryville, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- Insmed Incorporated (San Diego, CA)
- …for each other, 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 ... (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)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet 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
- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to ... fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial + Represent US Medical… 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
- Coty (Morris Plains, NJ)
- Senior Manager, US Regulatory Affairs ...policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D ... and Ingredient Support ** SENIOR MANAGER, US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking for smart leaders who are fast and passionate!**… more
- ITG Brands (Greensboro, NC)
- State Government Affairs Director **Location** North Carolina **City** Greensboro **Role Type** Permanent **WHO WE ARE** ITG Brands is the third-largest tobacco ... - JOB SUMMARY Responsible for leading Company's state government affairs strategy across a designated region of the United...regulators, and other stakeholders who shape the legislative and regulatory environment. The Director will serve as… more
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