- Merck (Jackson, MS)
- …from source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist , Regulatory ... through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, technology… more
- Bausch + Lomb (Springfield, IL)
- …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
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on ... devices in the US The Senior RA Specialist will also support related regulatory affairs...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more
- Kelly Services (Bristol, TN)
- ** Senior Validation Specialist - Direct Hire (Permanent)** **Location:** Bristol, TN **Reports to:** Technical Operations / Quality Leadership **Schedule:** ... and master data within LIMS and SAP. + Support CMC supplements, Annual Product Reviews, regulatory filings,...+ Support CMC supplements, Annual Product Reviews, regulatory filings, and documentation for product registrations. + Identify… more