- 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
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …to conduct global drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for marketed products and ... days per week on average. Position Summary The Associate Director , Regulatory CMC , is responsible...at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a… 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
- Mirum Pharmaceuticals (San Mateo, CA)
- …care, be real, get it done, and have fun, seriously. POSITION SUMMARY The Associate Director , Global Regulatory Affairs provides management of all aspects of ... documents). In collaboration with Regulatory project managers, Regulatory Labelling and Regulatory CMC ,...industry with a minimum of 8 years in Global Regulatory Affairs , experience with major Health Authority… more
- Takeda Pharmaceutical Company Limited (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 of… more
- Legend Biotech US (Somerset, NJ)
- …Serve as a liaison between internal departments (eg, research, toxicology, pharmacology, CMC , regulatory affairs ) and eternal partners (eg CROs) ... in the treatment of multiple myeloma. Legend Biotech is seeking a Director , Preclinical Project Development and Strategic Lead as part of the Early-stage… more
- Glycomine (Boston, MA)
- …etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and Program Leadership to ... with relevant team members involved in study set up ( CMC , Reg, etc). Ensure timeline collection of all start-up...prior to each site activation. Work closely with the Director of Clinical Operations to review the study timelines… 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
- Lilly (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
- 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
