- Astellas Pharma (Northbrook, IL)
- ** Head of Regulatory Affairs and Pharmacovigilance Operations** Do you want to be part of an inclusive team that works to develop innovative therapies ... encouraged to apply. **Purpose and Scope:** Reporting to the Head of Regulatory Affairs and Pharmacovigilance (RAPV), the Head of RAPV Operations is… more
- Ascendis Pharma (Palo Alto, CA)
- …programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and ... devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in...SOPs + Work closely with Commercial, Clinical Development, Medical Affairs , Pharmacovigilance , Biometrics, Core Team Members, Product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the entire product lifecycle with input from Research, Clinical Development, Regulatory Affairs , Quality, Pharmaceutical Development & Manufacturing, Legal and ... Regulatory , Safety and Quality (RSQ), the VP Global Head of Patient Safety (GHPS) is responsible and accountable...including academic medicine and industry experience in development, medical affairs and/or regulatory affairs . **Gilead… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …lead for meetings or responses to regulatory agencies * Work closely with Head , Pharmacovigilance and Medical Affairs to ensure standards of medical & ... be based in Princeton, NJ (Hybrid) and will report directly to the Head Pharmacovigilance and Medical Affairs - North America **Responsibilities:** * Plan,… more
- Astellas Pharma (Northbrook, IL)
- …alignment across development functions, including TAHs, Medical Science Heads, CPED, Pharmacovigilance , and Regulatory Affairs , optimizing data strategies ... statistics. This role will report to the SVP, Global Head of QSEQ, and as a member of QSEQ...quantitative approaches in portfolio decisions. + Support clinical development, regulatory , pharmacovigilance , and medical affairs … more
- Astellas Pharma (Cambridge, MA)
- …enterprise objectives. -Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to ... ** Head of Solid Tumor Clinical Development** Do you...and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development… more
- Bausch Health (Bridgewater, NJ)
- …effectively with cross-functional teams such as Business Development, Clinical Operations, Pharmacovigilance , and Regulatory Affairs , to ensure seamless ... drive our collective progress and impact. The Vice President, Head of Development will lead all ongoing programs as...the R&D organization and will work closely with our regulatory , pharmacovigilance , operational and commercial leaders to… more
- Sanofi Group (Morristown, NJ)
- …experience in Rheumatology or other relevant immunology therapy area + Knowledge of pharmacovigilance and local regulatory process. + Strong business acumen and ... **Job Title:** US Medical Franchise Head , Rheumatology **Location** : Cambridge or Morristown **About...team, as a valued strategic partner with Clinical, Commercial, Regulatory and Market Access to bring innovative therapeutic solutions… more
- Takeda Pharmaceuticals (Boston, MA)
- …drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... Global Labeling and works under the direction of the Head of Global Labeling and is: + Responsible, for...experience in the biopharmaceutical industry (eg, safety, ad promo, regulatory strategy, medical affairs , etc.). Up to… more
- Ascendis Pharma (Palo Alto, CA)
- …for employees to grow and develop their skills. The Associate Director, Global Pharmacovigilance Operations reports directly to the Head of Global PV Operations. ... Under the direction of the Head of Global PV Operations, is responsible for all...be collected, reported, and handled in accordance with global/local regulatory requirements and company policies + Responsible for operational… more