- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and… more
- Merck & Co. (Upper Gwynedd, PA)
- … issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC...Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , … more
- BioSpace (Indianapolis, IN)
- …them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to ... collate the necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director , Regulatory Affairs - Plasma Services in Boca Raton, ... Florida! The Associate Director , Regulatory Affairs - Plasma...and Establishment License Applications, and other related documents or CMC supplement submissions as directed to support the company.… more
- Stoke Therapeutics (Bedford, MA)
- …Collaborate with cross-functional teams including Process Development, Quality, and Regulatory Affairs . Author technical reports, method development summaries, ... of innovative oligonucleotide-based therapeutics. This position will report into the Director , CMC . Key Responsibilities: Develop, optimize, and validate UPLC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage ... 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)
- …radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in… more
- Lilly (Indianapolis, IN)
- …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
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... 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
- 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
- AbbVie (North Chicago, IL)
- …. Job Description The Associate Director , Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …scientific degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas ... of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Information Management system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC RA) or other relevant ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and… more
- BeOne Medicines (Emeryville, CA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … 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 ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Merck (Upper Gwynedd, PA)
- …Process Development, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory Strategy Development, ... CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical... management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
