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Associate Director, Regulatory Operations - Hybrid
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Full-time
- PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs.
- This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
- The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
- Key ResponsibilitiesCollaborate with the regulatory team, and cross-functional team members and external contractors/vendors/consultants as needed, to support the planning, preparation, formatting, publishing, QC, submission and archiving of global regulatory submissions (i.e., INDs/CTAs/BLAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc).
- Provide project management support in generation of timelines for Regulatory interactions and submissionsOrganize, archive, and track Health Authority correspondences, submissions, and questions/commitmentsCollaborate with our external publishing vendor(s) on submission publishing activities to assure on time regulatory submissions in accordance with project goals and timelines.
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