Regulatory Affairs Jobs at Sun Pharma | Chemistry Candidates Apply
Are you looking for Regulatory Affairs Jobs in a leading pharmaceutical company? Sun Pharma Careers offers an excellent opportunity for professionals who want to grow in Regulatory Affairs Jobs within a global research-driven organization. This Executive – Regulatory Affairs role at Sun Pharma Jobs is ideal for candidates seeking long-term growth, exposure to international markets, and a supportive work culture.
About Sun Pharma
Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and a trusted global leader in specialty and generic medicines. With a strong presence across more than 100 countries, Sun Pharma Careers provides professionals with opportunities to work on international regulatory frameworks, innovative research, and high-quality pharmaceutical products. Sun Pharma Jobs are known for fostering growth, accountability, and collaboration, making it a preferred destination for Regulatory Affairs Jobs worldwide.
- Job Title: Executive – Regulatory Affairs
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A
- Location: Baroda
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.
Key Responsibilities
- 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 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.
- Geographic Scope/ Market: South Africa
Travel Estimate: NA
Job Requirements
- Educational Qualification: Graduate: M.Sc /M.Pharm
- Experience: 1-4 years of tenure.
