- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Executive Director and Head , CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + ... Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence changing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB** ... to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates success in influencing without… more
- Actalent (Bridgewater, NJ)
- Job Title: Head of Regulatory AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ. Reporting to the ... with the R&D, Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of… more
- Sanofi Group (Cambridge, MA)
- …for both drug substance and drug product, with strong knowledge of quality, regulatory affairs , and manufacturing and supply. + **Proven ability** to deliver ... in helping our teams accelerate progress. Join our Synthetics CMC Development team in R&D as a ** Head...and commercial phases, including process design, characterization, validation, and regulatory filings. + ** CMC and GMP Knowledge**… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... asset strategy, working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , and pre-clinical development in this regard.… more