- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Manufacturing USA, Inc. is seeking a CMC Submissions Lead in Cambridge, MA with the following requirements: ... strategy, establish submission structure in electronic common technical document format for CMC Module 3 information; Written and oral communication skills in regard… more
- Lilly (Philadelphia, PA)
- …generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions including overall submission project, ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific … more
- Regeneron Pharmaceuticals (Troy, NY)
- …global markets. + Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local ... are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions . This position would focus on… more
- Sanofi Group (Bridgewater, NJ)
- …and contingencyplanning and mitigation of identifiedregulatoryrisks **Manage global regulatory submissions and dispatches of CMC packages for new ... and supplements, response submissions etc.** + Plan submissions and CMC dossier/package strategies per the...other health authorities including international with local/regional teams + Lead the Regulatory CMC content of meetings… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Develop meaningful and collaborative relationships with cross-functional teams and leaders. + Lead CMC strategies, assess risks, and develop contingency plans, ... that ensures "right first time" global approvals of CMC regulatory (Biologics) submissions , and "right to...licensure and right to operate of Gilead's operations. + Lead the execution of these global CMC … more
- AbbVie (North Chicago, IL)
- … CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual reports, supplements ... Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners to deliver products to… more
- Lilly (Indianapolis, IN)
- …CMC technical knowledge and Regulatory Science expertise to drive Regulatory CMC strategies and develop submissions for marketing authorizations. The ... technical expertise, to strengthen submission or minimize risk. * Reviews and approves CMC documents for global regulatory submissions , including submissions … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …manage and prioritize multiple complex projects*Interface with the Health Authorities for CMC submissions and CMC -related issues, with guidance and ... practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for...regulatory assessments on change controls + Prepare and manage CMC submissions for all global markets while… more
- Pfizer (Kalamazoo, MI)
- …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions , representing the ... requirements projects across the Department. + Responsible for the development of CMC documentation, coordination and management of global submissions , including… more
- Takeda Pharmaceuticals (Boston, MA)
- …having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred. + ... which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization. + Lead team members… more
- Bausch + Lomb (Columbus, OH)
- …**Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for prescription ... with R&D and Quality organizations to prepare and maintain CMC sections of submissions and respond to...Supply Chain as appropriate in a timely manner. + Lead and drive all CMC submission activities… more
- Takeda Pharmaceuticals (Lexington, MA)
- …therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory ... as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development,...for projects/products within respective modalities. + Support and/ or lead assigned global regulatory submissions (eg, Core… more
- Astellas Pharma (Westborough, MA)
- …or product and the application. **Essential Job Responsibilities:** + Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice ... regulatory agencies. Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy. Ensures proper CMC Dossier… more
- BeiGene (Emeryville, CA)
- …through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy...therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and… more
- Boehringer Ingelheim (Athens, GA)
- …delegated responsibilities in the areas of Analytical, Formulations, Process, Regulatory CMC , Packaging and Operations. The Technical Development Leader must work ... (GDL), departmental project leaders and functional experts (as appropriate). + Lead multi-disciplinary global teams in line with Boehringer Ingelheim values and… more
- Bristol Myers Squibb (Devens, MA)
- …specifications + Serve as author/reviewer for analytical sections of CMC submissions and responses to regulatory questions + Lead analytical method transfer ... Read more: careers.bms.com/working-with-us . **Title: Gene Editing Materials Analytical Program Lead ** **Location: Seattle, WA or Warren,** At Bristol Myers Squibb… more
- Takeda Pharmaceuticals (Lexington, MA)
- …member of External Biologics Supply Operations Team. Represent External Biologics Supply on CMC team. + Lead across multiple projects in a timeline-driven work ... best of my knowledge. **Job Description** **Job Title** : External Technical Services Lead **Location** : Lexington, MA **About the role:** As an External Technical… more