Regulatory Associate Job at Sun Pharma | Chemical Science Career
Are you looking for a Regulatory Associate Job or planning to build a Chemical Science career in the pharmaceutical industry? Sun Pharmaceutical Industries Ltd. is offering an excellent Sun Pharma career opportunity for the role of Executive – Regulatory Affairs at its R&D center in Baroda. This role is ideal for candidates with M.Sc or M.Pharm qualifications who want to grow in regulatory affairs, dossier preparation, and product lifecycle management. Professionals interested in regulatory functions can start or advance their Chemical Science career with one of the leading pharmaceutical companies in India.
About Sun Pharma
Sun Pharmaceutical Industries Ltd. is one of the largest pharmaceutical companies in India and a leading global specialty generics company. The company develops, manufactures, and markets a wide range of pharmaceutical formulations and active pharmaceutical ingredients across many therapeutic areas. A Sun Pharma career provides excellent opportunities for professionals pursuing a Chemical Science career, including roles such as Regulatory Associate positions in research and regulatory affairs. With advanced R&D facilities and a strong global presence, Sun Pharma continues to create growth opportunities for scientists and pharmaceutical professionals worldwide.
- Job Title: Executive – EM RA
- Location: Tandalja, Baroda
- Qualification: M.Sc/M.Pharm
- Tenure: 1-4 years
Job Description
Regulatory submission of new products, renewals, variations, response to queries, and life cycle management for MENA markets through the preparation of quality dossiers enabling timely approvals.
Area of Responsibility
- New submissions/Renewals:
- Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
- Review documents (Development report, scale-up report, specification, stability protocol), artworks, etc., before the initiation of Exhibit batches for adequacy.
- Approval:
- Review & prepare response to deficiency, enabling approval of products filed to the regulatory agency.
- Lifecycle management for drug formulations:
- Prepare and review variations as per the country-specific requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products, etc.
- Regulatory compliance:
- Prepare, review, and circulate the approval package with the product history sheet to stakeholders upon receipt of approval and update the same based on queries and variations.
- Ensure reposition of comprehensive product information into a central repository.
- Review regulatory filing impact of variations, change controls, etc.
