Regulatory Affairs Jobs at Sun Pharma | Chemistry Graduates Apply
Are you looking for Regulatory Affairs Jobs in a leading pharmaceutical company? Sun Pharma Jobs offer an excellent opportunity for professionals with 1–4 years of experience to join as an Executive – Regulatory Affairs at Baroda (Tandalja – R&D). If you are aiming to build a strong career in regulatory submissions, lifecycle management, and compliance, this is your chance to grow with Sun Pharma Careers and create your own sunshine. If you are seeking Regulatory Affairs Jobs in a reputed pharmaceutical organization, this Executive – Regulatory Affairs position at Sun Pharma, Baroda, is a strong opportunity to advance your professional journey.
About Sun Pharma
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies, trusted globally for high-quality and affordable medicines. With a strong presence in research and development, Sun Pharma offers outstanding growth opportunities through Sun Pharma Jobs across Regulatory Affairs, R&D, Manufacturing, and Corporate functions.
Executive – Regulatory Affairs | Sun Pharma Jobs
Location: Tandalja – R&D, Baroda
Company: Sun Pharmaceutical Industries Ltd
Business Unit: R&D1 Regulatory Affairs
Job Grade: G12A
Geographic Scope/Market: South Africa
Travel Estimate: NA
About the Role – Regulatory Affairs Jobs
As part of Sun Pharma Careers, the Executive – Regulatory Affairs role focuses on regulatory submission of new products, renewals, variations, response to queries, and Lifecycle management for MENA markets through the preparation of quality dossiers enabling timely approvals.
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey, and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.
Area of Responsibility – Sun Pharma Jobs
1. 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 initiation of Exhibit batches for adequacy.
2. Approval
- Review & prepare response to deficiency, enabling approval of products filed to the regulatory agency.
3. 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.
4. 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 the central repository.
- Review regulatory filing impact of variations, change controls, etc.
Job Requirements – Regulatory Affairs Jobs at Sun Pharma
Educational Qualification
- Graduate: M.Sc / M.Pharm
Experience
- Tenure: 1–4 years.
