Regulatory Affairs Job at Sun Pharma | MSc Chemistry Graduates Apply Now
Are you looking for a Regulatory Affairs job in a leading pharmaceutical company? Sun Pharma Careers presents an excellent opportunity for an Executive – Regulatory Affairs role in the R&D division at Baroda. This position is well-suited for candidates seeking an MSc Chemistry job or M.Pharm role with hands-on exposure to regulatory submissions, lifecycle management, and MENA market compliance within a globally recognized organization.
About Sun Pharma
Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and a globally respected leader in specialty generics. Through Sun Pharma Careers, the company offers rewarding Regulatory Affairs jobs and structured growth paths for professionals seeking MSc Chemistry jobs and pharmaceutical R&D careers. Known for quality, compliance, and innovation, Sun Pharma provides an ideal platform for long-term professional success.
Job Details
- Title: Executive – Regulatory Affairs
- Location: Tandalja, Baroda
- Educational Qualification: Graduate: M.Sc /M.Pharm
- Experience: Tenure: 1-4 years
Job Description
Regulatory submission of new products, renewals, variations, response to queries, and Life cycle management for MENA markets through 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 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 approva,l 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.
Geographic Scope/ Market: MENA-GCC, UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain, etc.)
Travel Estimate: NA
