Senior Executive - India Regulatory Affairs

About the Role

Join Sun Pharma as a Manager II in the India Regulatory and Business Continuity team under R&D1 Regulatory Affairs at the Baroda location. At Sun Pharma, we encourage you to "Create your own sunshine" by fostering growth, taking ownership of your career, and thriving within a collaborative environment. We strive to be "Better every day" through continuous improvement and teamwork.

Primary Responsibilities

• Assess regulatory strategies required for product registration within the Indian market.
• Collaborate with cross-functional teams to obtain necessary documentation for filing products in India.
• Review Chemistry, Manufacturing, and Controls (CMC) documentation adhering to regulatory standards.
• Evaluate specifications for bulk drugs and formulations to meet regulatory expectations.
• Analyze clinical trial and bioequivalence study documents to support regulatory submissions.
• Conduct literature searches using various online resources, following the application strategy.
• Draft rationales concerning safety and efficacy for new drugs or fixed-dose combinations by referencing published literature.
• Prepare executive summaries for SEC referrals involving drugs not yet approved in India.
• Gather finalized CMC, clinical trial, and bioequivalence documents from cross-functional teams and compile dossiers for submission.
• File New Drug, Supplementary New Drug, and Fixed Dose Combination applications via the SUGAM portal to obtain domestic manufacturing, marketing, and clinical trial approvals.
• Examine draft labels, specimens, and cartons for compliance.
• Develop prescribing information based on international prescribing data.

Qualifications and Experience

• Educational Qualification: Graduate or Master's degree in Pharmacy (M-Pharm).
• Professional Experience: 8 to 10 years relevant experience in regulatory affairs.

Additional Information

Travel requirements: None specified.

At Sun Pharma, your well-being and success are paramount. We offer comprehensive benefits and professional development opportunities, encouraging teamwork and impactful contributions.

Disclaimer: This job description outlines general responsibilities and qualifications associated with this role but is not exhaustive. The company reserves the right to modify duties and responsibilities as necessary to align with business needs and employee experience.