- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Head of CMC Regulatory Affairs - Small Molecules** **KEY RESPONSIBILITIES** The ... Head of CMC Regulatory Affairs - Small Molecules is responsible for Gilead's global portfolio of small molecule products in CMC Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head , CMC Regulatory Affairs , Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… 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
- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Director, Commercial Regulatory Affairs , in collaboration with Head , Regulatory Affairs and CMC -RA, will review and assess all commercial ... creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the post-approval… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program ... regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC ...necessary, directly and indirectly. As part of the RAV CMC team, you will report to the Head… more
- CSL Behring (King Of Prussia, PA)
- …business objectives and current health authority expectations. o Provides communications between Global Regulatory Affairs CMC and partners within GRA and ... you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located...the GRA CMC Leadership Team, support the Head GRA CMC in developing regulatory… more
- Sanofi Group (Cambridge, MA)
- **Global Regulatory Affairs Lead (GRL)** **Mission statements** + The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for ... of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in early and… more
- Sanofi Group (Framingham, MA)
- …with internal and external partners. + Develop strategies in collaboration with Global Regulatory Affairs as well as the Business Unit Franchise Heads and ... drug substance processes on recombinant products. In cooperation with the global head of Injectables representing the Drug product part of those recombinant products… more
- Sanofi Group (Cambridge, MA)
- We are currently seeking a Global Regulatory Affairs Lead (GRL) who will be the fully accountable decision maker for the development & execution of creative, ... relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global), in early and… more
- Novo Nordisk (Lexington, MA)
- …including Non-Clinical Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs . Interfaces with both ... functions such as Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC , and Regulatory Affairs to deliver and drive… more
- Teva Pharmaceuticals (West Chester, PA)
- …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
- Randstad US (Cambridge, MA)
- …+ Knowledge of pharmaceutical industry and Project management experience within Medical Affairs , Clinical Research, Regulatory , CMC , Marketing or other ... Experience managing program level budgets across multiple projects + Knowledge of regulatory and compliance guidelines governing medical affairs + Applied… more