- Protagonist Therapeutics (Newark, CA)
- …ability to effectively lead projects with internal and external resources. Experienced with regulatory CMC filings in IND, NDA, IMPD, PAS covering all phases ... in identification and qualification of impurities. Contribute to Quality and CMC -related regulatory correspondence. Maintain a current understanding of peptide… more
- Programmable Medicine Operatin (Redwood City, CA)
- …Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records ... our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As… more
- HCA Medical City Fort Worth Hospital (Fort Worth, TX)
- …treatments, to the medical team promptly. Ensure compliance with regulatory standards, documentation requirements, and quality improvement initiatives. Quality ... conferences, workshops, and pursuing certifications related to cardiovascular nursing (eg, CCRN, CMC , CSC). Client Details Address 900 8th Ave City Fort Worth State… more
- Lilly (Philadelphia, PA)
- …communities through philanthropy and volunteerism. **Position Overview:** The Manager, Manager- CMC Regulatory is responsible for the preparation and delivery ... of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. **Responsibilities:** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + ... **1. Strategy and Roadmap Development** + Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise… more
- Merck (Rahway, NJ)
- …strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of ... as needed. **Primary Responsibilities:** + Lead a small team of CMC regulatory scientists responsible for new modality or traditional solid-oral small molecules… 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
- 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global… 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
- United Therapeutics (Research Triangle Park, NC)
- …manager, project teams, and functional area representatives to devise and implement sound regulatory CMC and labeling strategies. + Manage and lead regulatory ... with UT manufacturing and quality groups, contract and partner organizations regarding CMC regulatory issues and provide strategic CMC regulatory … 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 (Athens, 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
- AbbVie (North Chicago, IL)
- …Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Program Manager, CMC Dossier Management assists with the development and oversight of… more
- Sanofi Group (Framingham, MA)
- …Leader leads a cross-functional CMC team with representatives from CMC Development, Manufacturing and Supply, Quality, Dossiers, Regulatory , Demand and ... the CMC contributions to pre-clinical, clinical and validation (DS/DP), and CMC elements for regulatory submissions and consultations. + He/she evaluates the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. * Provide strategic regulatory ... Team (PLRT) and in collaboration with US RA Labeling Content, provide CMC regulatory support during Annual, CCDS, or ad-hoc product labeling reviews for marketed… more
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
