- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, GRA CMC Small Molecules where...Director Global Regulatory Affairs CMC . **How you… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC ... risk mitigation plans. Shadows leads while they develop and execute robust CMC regulatory strategies. + Under the guidance of more senior staff, oversees the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution ... marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Organon & Co. (Plymouth Meeting, PA)
- …Scientist ( Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Regulatory Affairs Devices and Combination ... responsibilities. + Develops and implements policies and procedures within the regulatory affairs department. + Analyzes legislation, regulation, and guidance… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more