Department: Regulatory Affairs

Industry: Active Pharmaceutical Ingredients (API)

Designation: Executive – Regulatory Affairs

Experience: 3–5 Years

Qualification: B.Pharm / M.Pharm

Job Location: Padra, Vadodara, Gujarat

Job Purpose To manage regulatory documentation, dossier preparation, submissions, and regulatory compliance activities for Active Pharmaceutical Ingredients (APIs) in accordance with applicable national and international regulatory requirements.

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.

Positive 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.

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