- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …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
- Parexel (Tallahassee, FL)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, dedicated ... affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …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
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …budgeting of CMC resources to conduct monitoring oversight tasks. The Manager , Clinical Operations will also coordinate reporting and review of CRO related Key ... **Job** **Summary** The Manager , Clinical Operations works closely with the OPDC...manage monitoring oversight activities including managing Clinical Monitoring Consultants ( CMC ) contracted to perform monitoring oversight duties as well… more
- Parexel (Tallahassee, FL)
- …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. (Tallahassee, FL)
- … 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 (Tampa, FL)
- …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
- Sanofi Group (Orlando, FL)
- …diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D ... support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration… more