- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be ... Affairs Impact and Omnichannel strategy. This is a global role which will work across regions, functions and...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… 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 ... teamsWith oversight from the VP of Regulatory Affairs , lead the development and implementation of global... Affairs , lead the development and implementation of global regulatory strategy plans to facilitate efficient… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...vision. This position will report directly to the Executive Director of Medical Affairs . Together with the… more
- Insmed Incorporated (NJ)
- …regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory ... agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead...of an exciting, passionate, high profile, high impact Medical Affairs team, and work in a highly dynamic and… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices.… more
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