- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Amicus Therapeutics (Marlow, OK)
- Director , CMC RA Location Marlow,...matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of ... # of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1315) Job Brief Director , CMC RA Amicus Therapeutics… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...oversee the development and execution of regulatory CMC development and registration strategies. RA … more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the ... CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to ... higher-level manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Regulatory Affairs ( RA ) Fellowship within the Chemistry, Manufacturing ... areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC ...resolution of comments from FDA with assistance from the Director /delegate CMC RA as needed.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + ... for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure... CMC control strategies and quality compliance to CMC RA and PDM leadership. + Develops… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more