Job Openings
Assistant Manager- Regulatory Affairs (Row Market)
About the job Assistant Manager- Regulatory Affairs (Row Market)
Job Title: Assistant Manager- Regulatory Affairs (Row Market)
Job Location: Maharashtra
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Role & Responsibilities
- Ensure timely preparation and submission of registration dossiers, responses to Ministry of Health (MOH) queries, renewal applications, and variation filings for Rest of World (ROW) markets in accordance with predefined timelines.
- Coordinate and finalize responses to deficiencies or queries raised by regulatory authorities on submitted applications.
- Review technical documents related to products under development, for filing and commercialization purposes.
- Evaluate and approve technical documentation received from R&D and manufacturing units.
- Review initial and updated approval packages to ensure alignment with granted approvals.
- Maintain lifecycle management activities and ensure proper archival of regulatory documentation in internal databases.
- Arrange and compile supportive documentation for tender-related submissions.
- Act as mediator and coordinate with regulatory authorities, customers, and business partners for dossier submissions, query responses, renewals, and variation applications.
- Collaborate with manufacturing units to collect supporting data required for new applications, query responses, renewals, and variation submissions.
- Interface with various departments, including FR&D, AR&D, Bioequivalence (BE), Business, and Operations teams, to obtain necessary data for regulatory filings.
- Possess strong knowledge of global regulatory requirements, including new submissions, post-approval changes, eCTD structure, ICH guidelines and CMC requirements for both Regulated and ROW markets.
- Demonstrated experience in leading and mentoring team members by providing strategic regulatory guidance, effectively managing workload pressures, simplifying complex regulatory strategies, and ensuring timely and compliant submissions.
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