- J&J Family of Companies (Horsham, PA)
- …be located in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director , CMC Regulatory Affairs Biologics New Modalities will lead a team ... Medicine R&D is recruiting for a Director , CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs...regulatory requirements and expectations. Communicate critical issues to Senior Management. + Represent CMC RA on… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. You… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- Lilly (Indianapolis, IN)
- …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...strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory ...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial ... that make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
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