Executive Opportunity in Regulatory Affairs | Sun Pharma Careers | Apply Now
Discover rewarding growth pathways with Sun Pharma Careers, offering a dynamic role in Regulatory Affairs Jobs for professionals seeking impactful involvement in pharmaceutical compliance, dossier submissions, and lifecycle management for global markets. This Executive – Regulatory Affairs position provides an excellent opportunity to advance within a respected healthcare leader committed to innovation, collaboration, and regulatory excellence.
Job Details:
- Job Title: Executive – Regulatory Affairs
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A
- Location: Baroda
- Location: Tandalja – R&D
About The Company:
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.
Job Description | Sun Pharma Careers
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 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 approval package with 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 central repository.
- Review regulatory filing impact of variations, change controls, etc.
Educational Qualification Required For Sun Pharma Careers:
Graduate: M.Sc /M.Pharm
Experience
Tenure: 1-4 years
Why Join This Company?
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
