- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Director, CMC Regulatory will leverage CMC technical knowledge and regulatory ... science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… 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 (Emeryville, 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
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Sanofi Group (Morristown, NJ)
- …that model the Sanofi and GRA Values/Principles/Competencies. + Oversees the development of CMC regulatory strategy and regulatory risk assessments for all ... including directly with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the highest Probability of Success (POS).… more
- Taiho Oncology (Princeton, NJ)
- …Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI)… 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
- Parexel (Augusta, ME)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager** to join a growing, dedicated client ... affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive… 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
- 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... lifecycle management and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings, market expansions,… more
- Sanofi Group (Framingham, MA)
- …organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's ... approval of CMC dossiers + Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from… more
- Merck (West Point, PA)
- …+ Prepare clear statistical content for Chemistry, Manufacturing, and Controls ( CMC ) documentation; assist with regulatory queries using sound statistical ... **Job Description** **Sr. Statistician - Chemistry, Manufacturing, and Controls ( CMC )** R3 Under the general supervision of a senior staff member in Center for… more
- Gilead Sciences, Inc. (Washington, DC)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience ... and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and… more
- Lundbeck (Deerfield, IL)
- …effective regulatory affairs cross-functional team on a dotted-line basis ( CMC , Regulatory Operations, US Labeling, Promotion Compliance & Scientific ... Director US Regulatory Strategy Requisition ID: 7214 Location: Deerfield, IL,...to candidates within the United States** The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory… more
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