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 robust 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 operati

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