- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …to work in our office three days per week on average. Position Summary The Associate Director , Regulatory CMC , is responsible for contributing ... to/assisting with the development and implementation of global regulatory CMC strategies supporting investigational and marketed small molecules therapeutics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products ... Job DescriptionGRACS CMC - Associate Principal Scientist, ...regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC , Statistical Design of Experiments (DOE),… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical… more
- Eisai, Inc (Exton, PA)
- …well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 stakeholders.… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... Director in Biologics Cell Culture Sciences group and working...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… 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 ... related documents). In collaboration with Regulatory project managers, Regulatory Labelling and Regulatory CMC , oversees the development of content and… more
- Xaira Therapeutics (Brisbane, CA)
- …and London. About the Role We are seeking a highly skilled and proactive Associate Director , Research Project Manager to oversee the planning and execution of ... IND filing. Deep understanding of biologics R&D processes, including nonclinical, CMC , and regulatory components. Strong analytical, planning, and organizational… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …employment application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
- Bristol-Myers Squibb Company (Summit, NJ)
- …strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product ... but not limited to, continued process verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class… more
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… 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. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US… more
- Lilly (Indianapolis, IN)
- …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 for Lilly's… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops ... and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development… more
- Merck (Upper Gwynedd, PA)
- …Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products ... **Job Description** GRACS CMC - Associate Principal Scientist, ...regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of… more
