We’re Hiring | General Manager – Regulatory Affairs Industry: Pharmaceutical / API

We are looking for an experienced and dynamic General Manager – Regulatory Affairs with 16–17 years of experience in the pharmaceutical industry, preferably with solid expertise in API regulatory affairs and Drug Master File (DMF) management.

? Key Responsibilities

- Coordinate with cross-functional teams to ensure timely regulatory submissions and fulfilment of commitments.
- Review Key Starting Material (KSM) specifications, analytical procedures, and vendor-related documents, including ROS, GMP, TSE/BSE declarations, willingness-to-be-inspected declarations, change notification declarations, solvent and impurity lists, process validation reports/declarations, and stability data.
- Review approved vendor lists in alignment with submitted and current DMFs.
- Review specifications and analytical procedures for raw materials, packing materials, in-process materials, intermediates, and APIs, ensuring alignment with Batch Manufacturing Records (BMRs).
- Review Certificates of Analysis (CoAs) against respective specifications.
- Prepare Open DMFs (ODMFs), technical packages, and compile Drug Master Files (DMFs) as per customer requirements and regulatory agency guidelines.
- Prepare responses to customer queries and regulatory authority queries.




- Manage customer notifications and prepare DMF amendments arising from changes in processes or documentation.
- Prepare and review annual reports as per applicable regulatory requirements.
- Ensure monograph compliance for submitted DMFs.
- Review change controls and conduct impact assessments related to submitted DMFs.
- Lead the regulatory affairs team to ensure compliance with organizational policies, procedures, and Integrated Management System (IMS) requirements, including ISO 9001, ISO 14001, and ISO 45001.
- Identify potential risks and opportunities and implement appropriate mitigation measures to support quality, compliance, and operational excellence.

? Desired Candidate Profile

- 16–17 years of relevant experience in the pharmaceutical industry.
- Strong expertise in API regulatory affairs, DMF compilation, submissions, amendments, and annual reports.
- Sound knowledge of regulatory documentation, analytical procedures, vendor qualification documents, and change control management.
- Excellent leadership, communication, and cross-functional coordination skills.

? Interested candidates can share their updated CV at: [email protected]

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📌 GM Regulatory Affairs (Vadodara)
🏢 Apicore Pharmaceuticals
📍 Vadodara