🚨 We’re Hiring | Regulatory Affairs Manager – US Market
📍 Location: Malad, Mumbai
🏭 Industry: Pharmaceutical Formulations
💼 Experience: 7–15 Years
Key Responsibilities:
- Lead and manage regulatory submissions, renewals, amendments, and approvals for the US market.
- Prepare, review, and compile CTD / eCTD dossiers as per regulatory requirements.
- Coordinate with R&D, QA, QC, Manufacturing, and other cross-functional teams for documentation and submissions.
- Handle regulatory deficiency responses, queries, variations, supplements, and post-approval lifecycle activities.
- Ensure compliance with USFDA guidelines and applicable international regulatory requirements.
- Review technical documents including stability data, specifications, validation reports, and product-related dossiers.
- Support new product launches and ensure timely regulatory approvals.
- Maintain regulatory records and monitor timelines for submissions and renewals.
- Assist during regulatory audits and inspections
Desired Candidate Profile:
✅ Graduate / Post-Graduate in Pharmacy / Life Sciences
✅7–15 years of experience in Regulatory Affairs within pharmaceutical formulations
✅Strong knowledge of USFDA regulations, CTD/eCTD submissions, and dossier compilation
✅Experience in ANDA/NDA documentation and lifecycle management preferred
📩 Interested candidates may share their updated resume at:
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