Executive Jobs at Sun Pharma | Chemistry Candidates Apply
Are you looking for Executive Jobs in a leading pharmaceutical company? Sun Pharma Jobs offers an exciting opportunity for professionals seeking growth in Regulatory Affairs within R&D. Sun Pharmaceutical Industries Ltd is inviting applications for the role of Executive – Regulatory Affairs at its Baroda location. This role is ideal for candidates looking to build a rewarding career through Sun Pharma Careers while contributing to global regulatory submissions and lifecycle management.
About Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and a leading global specialty generics player. Known for innovation, quality, and patient-centric solutions, Sun Pharma Careers provides professionals with exposure to global markets, advanced R&D, and long-term career growth. With a strong presence across more than 100 countries, Sun Pharma Jobs are highly sought-after Executive Jobs in the pharmaceutical industry.
Executive – Regulatory Affairs
Business Unit: R&D1 Regulatory Affairs
Job Grade: G12A
Location: Baroda
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.
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.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 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, the Middle East, GCC
Travel Estimate
NA
Job Requirements
Educational Qualification:
Graduate: M.Sc / M.Pharm
Experience:
Tenure: 1–4 years.
