SUN PHARMAVadodara, Gujarat, IndiaOn-siteFull-time8–10 years
Listing expiry: 19 October 2026
About the role
Role Overview
The role involves managing regulatory affairs activities for pharmaceutical products intended for registration in India. Responsibilities include evaluating regulatory strategies, coordinating with cross-functional teams, reviewing chemistry, manufacturing and controls (CMC) documentation, clinical trial and bioequivalence study documents, and preparing regulatory dossiers and applications. The position also involves reviewing product specifications, labelling, prescribing information, and scientific literature to support regulatory submissions and demonstrate the safety and efficacy of pharmaceutical products.
Key Responsibilities
- Evaluate regulatory strategies for products to be registered in India.
- Coordinate with cross-functional teams to obtain the documents required for product registration and regulatory filings in India.
- Review chemistry, manufacturing and controls (CMC) documents for inclusion in regulatory dossiers in accordance with applicable regulatory guidelines.
- Review specifications for bulk drugs and formulations against regulatory expectations.
- Review clinical trial and bioequivalence study documents for inclusion in regulatory applications.
- Search scientific literature through relevant websites in accordance with the regulatory application strategy.
- Prepare rationales concerning the safety and efficacy of new drugs and fixed-dose combinations (FDCs) by referring to published literature.
- Prepare executive summaries for Subject Expert Committee (SEC) referrals concerning drugs that have not been approved in India.
- Obtain final CMC, clinical trial (CT), and bioequivalence (BE) documents from cross-functional teams and compile dossiers for regulatory submission.
- File new drug (ND), subsequent new drug (SND), and fixed-dose combination (FDC) applications through the SUGAM portal to obtain domestic manufacturing and marketing permissions or clinical trial permissions, as applicable.
- Review draft product specimens, labels, and cartons.
- Prepare prescribing information by referring to international prescribing information.
Qualifications & Experience
- Master's degree in Pharmacy (M.Pharm).
- Required experience: 8–10 years.
Additional Details
- Business unit: R&D1 Regulatory Affairs.
- Job grade: G11A.
- Travel estimate: Not applicable (NA).
- The employer emphasises professional development, personal growth, collaboration, employee wellbeing, and a supportive working environment.
- The job description represents the general nature and level of work associated with the position. It is not an exhaustive list of duties, and responsibilities may be changed or supplemented with comparable duties commensurate with the employee's experience and background.