- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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
- 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)
- We are hiring a Vice President to lead our CMC Program Management team. This position addresses a critical organizational challenge: coordinating Chemistry ... Manufacturing and Controls ( CMC ) activities across 80+ simultaneous programs within a rapidly...+ Cross-Functional Collaboration + Facilitate integration across R&D, manufacturing, regulatory , and quality teams to ensure alignment on timelines,… 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
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Parexel (Albany, NY)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role… more
- Bausch + Lomb (Rochester, NY)
- …structured phase gate processes. + Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical/biotech environment. + Excellent ... health in the future. **Objectives/Purpose of Job:** The Senior Manager is a member of the Pharma and Lens...Engineering Team within the Pharmaceuticals/Consumer business vertical. The Senior Manager leads a team of Primary and Secondary Packaging… more
- University of Rochester (Rochester, NY)
- …supervision, office workflows, accounts receivable collaboration, payer rules, compliance, and regulatory requirements. The Assistant Coding Manager must exhibit ... and internal equity considerations._ **Responsibilities:** GENERAL PURPOSE The Assistant Coding Manager serves as a key support leader within the assigned functional… more
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