- Careers Integrated Resources Inc (Atlanta, GA)
- …of regulatory guidelines. Job Description: Manage document preparation of CMC regulatory submission documents to Client standards and ensure final ... requirements. Manage the logistical process in the authoring system for CMC regulatory submissions. This process includes coordinating reviews in the review and… more
- Sunrise Systems Inc (Atlanta, GA)
- …Based out of New Brunswick NJ Job Description: Manage document preparation of CMC regulatory submission documents to Client standards and ensure final document ... requirements. Manage the logistical process in the authoring system for CMC regulatory submissions. This process includes coordinating reviews in the review and… more
- Axelon Services Corporation (Seattle, WA)
- …subject matter expert in multidisciplinary team setting, that includes non-clinical, clinical, regulatory , and CMC functions - Author, review, and approve ... 4. Generate in depth product characterization data packages for inclusion in regulatory submissions (with specific attention to Module 3 S.3.1. Elucidation of… more
- Careers Integrated Resources Inc (Newark, CA)
- …projects to meet departmental and organization goals. . Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables. ... Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP. . Perform Analytical assays such as HPLC (SEC, IEX, HIC, RP, affinity), ELISA, SDS-PAGE,… more
- Axelon Services Corporation (Devens, MA)
- Job Description: CMC Statistician Client Hybrid role, Devens OR New Brunswick site Work Schedule: Mon - Fri, Business hours This position is responsible for ... setting, statistical application in manufacturing processes, health authority filings, and regulatory responses. This role offers the opportunity to support the… more
- Lilly (Philadelphia, PA)
- …life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific … more
- BeiGene (San Mateo, CA)
- …Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix ... a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide leadership at a product level as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates success in influencing without… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Intern - CMC Regulatory Affairs - Biologics** **Foster City, CA** As a Gilead ... subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line with … more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Astellas Pharma (Westborough, MA)
- …remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects ... data required for regulatory submission packages. Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and Regulatory Science expertise to drive Regulatory CMC strategies and develop submissions for marketing authorizations. The ... and processes * Recognized internally and externally for broad knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Lundbeck (Deerfield, IL)
- …of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces ... Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with… more
- Takeda Pharmaceuticals (Lexington, MA)
- … CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA ... CMC member on the Global Regulatory CMC team. Serve as or act as the delegate for the GRA CMC Product Lead at Regulatory , Pharmaceutical Development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.… more
- AbbVie (North Chicago, IL)
- …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... teams to negotiate, influence, and provide strategic advice. Responsibilities: + Prepares CMC regulatory product strategies. Prepares and manages regulatory … more
- Merck (Rahway, NJ)
- …Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical ... for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products. The Co-op will assist… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the following + Provides… more
- Sanofi Group (Bridgewater, NJ)
- …Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, including direct ... and Regulatory Health Authorities. **Main responsibilities:** + Develops global regulatory CMC strategies and risk assessments for development projects… more
