- Parexel (Providence, RI)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... regulatory leads in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their ... 5 years' experience in pharmaceutical industry,** **preferred in a CMC regulatory related role** **Other Information/Additional Preferences:** **Extensive… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... Leads the Chemistry, Manufacturing, and Controls ( CMC ) & Combination Products (CP) Internal Medicine team....be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …related subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line ... the following:** A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs...in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus… more
- AbbVie (North Chicago, IL)
- … CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and ... FDA) regarding CMC matters. Scope of Responsibility: + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including… more
- Lilly (Indianapolis, IN)
- …life 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 ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Sanofi Group (Framingham, MA)
- …possible. Ready to get started? **Main Responsibilities:** **Develop and implement global regulatory CMC strategies** + Create strategies for development and ... CMC documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality standards + Comply with … more
- Lilly (Indianapolis, IN)
- …that 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 ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… more
- Lilly (Indianapolis, IN)
- …life 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 ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug ... Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and Controlslead for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health ... sections of regulatory submissions. + Experience with complex CMC regulatory submissions for both development and marketed products is differentiating.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …clinical development to commercial readiness. + Drive cross-functional alignment between R&D, Regulatory CMC , and Commercial Quality to enable robust, efficient, ... AND ASPECTS_** **Technical/Functional (Line) Expertise** + Deep understanding of global CMC regulatory requirements, inspection trends, and industry best… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- Boehringer Ingelheim (Duluth, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
- Kelly Services (South San Francisco, CA)
- …innovation and operational excellence. You'll work closely with cross-functional leaders across CMC , Drug Development, QA, Regulatory , and external partners to ... at navigating complex, matrixed teams and fostering strong cross-functional partnerships ( CMC , Regulatory , Clinical, Quality, etc.), both internally and… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... conjugates, peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory -to enable accelerated development and… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... execution from early development through commercialization, ensuring timely supply, regulatory readiness, and strategic coordination across all technical and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and ... the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed. **R** **equired… more
- Organon & Co. (Jersey City, NJ)
- …for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but ... across the product lifecycle + Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as needed. Technical Skills +… more
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