Job Responsibilities

- Preparation, compilation, review and maintenance of regulatory documents for API products.
- Preparation and submission of DMF (Drug Master File), ASMF and other regulatory dossiers.
- Handling documentation and regulatory submissions.
- Preparation and review of technical documents, including COA, specifications, analytical methods, stability data and validation documents.
- Coordination with QA, QC, Production and R&D; departments for regulatory documentation.
- Handling customer and regulatory queries related to product registration and documentation.
- Maintaining regulatory records, submission trackers and product registration status.
- Supporting WHO-GMP, GMP and other regulatory audits.
- Ensuring compliance with applicable national and international regulatory guidelines.
- Reviewing and updating regulatory documents as per changes in guidelines and requirements.

Candidates with experience in API manufacturing companies and exposure to domestic and international regulatory submissions will be preferred. 2– 6 years of experience in Regulatory Affairs in the API industry

Pay: ₹300,000.00 - ₹400,000.00 per year

Advantages

- Provident Fund

Work Location: In person

📌 Regulatory Affairs Executive (API PHARMA) (Bavla)
🏢 Skanttr Lifescience
📍 Bavla