Regulatory Affairs Executive

• Department: Regulatory Affairs
• Industry: Active Pharmaceutical Ingredients (API)
• Designation: Executive Regulatory Affairs
• Experience: 35 Years
• Qualification: B.Pharm / M.Pharm
• Job Location: Padra, Vadodara, Gujarat

Key Responsibilities

• Prepare, review, and compile regulatory dossiers for APIs, including DMF, CEP, ASMF, and other applicable regulatory submissions, as per market requirements.
• Prepare and maintain regulatory documents such as Quality Overall Summary (QOS), specifications, analytical methods, batch manufacturing information, and stability data.
• Coordinate the preparation and submission of regulatory documents for domestic and international markets.
• Review and compile technical documents received from Quality Assurance, Quality Control, Production, R&D, Analytical Development, and other cross-functional departments.
• Support responses to regulatory queries, deficiency letters, and requests for additional information from regulatory authorities and customers.
• Prepare and maintain Technical Data Packages, regulatory questionnaires, customer-specific documentation, and product-related compliance documents.
• Ensure timely preparation, review, and submission of regulatory documents in line with applicable regulatory guidelines and submission timelines.
• Track regulatory submission status, approval timelines, renewals, and commitments, ensuring proper documentation and follow-up.
• Assess the regulatory impact of changes related to API manufacturing processes, specifications, analytical methods, sites, and other product-related changes.
• Coordinate with internal departments for change control assessments and regulatory notifications or submissions, wherever applicable.
• Maintain updated regulatory files, submission records, approval documents, and product-specific regulatory databases.
• Support regulatory audits, customer audits, and inspections by providing the required documentation and regulatory information.
• Monitor applicable regulatory guidelines and updates relevant to API manufacturing and registration requirements.
• Required Skills and Competencies
• Practical experience in Regulatory Affairs within the API / Bulk Drug industry is mandatory.
• Working knowledge of API regulatory dossiers, including DMF, CEP, and ASMF.
• Understanding of ICH guidelines, applicable pharmacopoeial requirements, and relevant regulatory requirements for API registration.
• Experience in regulatory documentation, dossier compilation, document review, and query response preparation.
• Ability to coordinate effectively with cross-functional teams and manage multiple regulatory activities within defined timelines.
• Good written communication, documentation, analytical, and organizational skills.
• Proficiency in MS Office and regulatory documentation management.
• Preferred Candidate Profile
• Candidates with relevant experience in API manufacturing companies only.
• Experience handling regulatory documentation for domestic and/or regulated international markets will be preferred.
• Candidates with exposure to USFDA, EDQM, European regulatory requirements, and other international regulatory authorities will be an added advantage.
• Candidates from formulation-only regulatory affairs backgrounds will not be considered.