Regulatory Affairs job at Sun Pharmaceuticals | M Pharmacy Graduates | Apply Now
If you are searching for a Pharma job in regulatory affairs, this opportunity at Sun Pharmaceutical Industries Ltd could be a great career move. The company is hiring an Executive – Regulatory Affairs (US Group) for its R&D regulatory team. This Pharma job is ideal for professionals looking for a Regulatory Affairs job involving global regulatory submissions, compliance with USFDA and ICH guidelines, and coordination with cross-functional teams in the pharmaceutical industry.
- Job Title: Executive – Regulatory Affairs
- Location: Tandalja – R&D
About the Company
Sun Pharmaceutical Industries Ltd is one of the largest pharmaceutical companies in India and a leading global specialty generic pharmaceutical company. The company focuses on delivering high-quality medicines worldwide and provides excellent Pharma job opportunities across research, manufacturing, and regulatory functions.
At Sun Pharma, employees are encouraged to “Create your own sunshine” by growing continuously, taking charge of their journey, and collaborating with teams that thrive together.
Key Responsibilities
- Strong knowledge of USFDA, ICH guidelines, regional regulations (US, EU, India), and submission formats.
- Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), ANDAs, MAAs, and post-approval changes.
- Support regulatory strategy development for new products and markets.
- Coordinate with cross-functional teams (CDMO, R&D, Manufacturing) to gather required documentation and data.
- Respond to queries and deficiency letters from regulatory authorities.
- Maintain regulatory databases and track submission timelines and approvals.
Qualification
- Graduate: M.Pharm
Experience
- Tenure: 2-5 years of relevant experience
Why Join This Role?
Joining this Pharma job as an Executive – Regulatory Affairs (US Group) at Sun Pharmaceutical Industries Ltd offers an excellent opportunity to build a strong career in regulatory affairs within a global pharmaceutical organization. This Regulatory Affairs job provides valuable exposure to international regulatory frameworks such as USFDA and ICH guidelines, along with hands-on experience in preparing and managing regulatory submissions like NDAs, ANDAs, and MAAs. Professionals in this Pharma job will collaborate with cross-functional teams, including R&D, CDMO, and Manufacturing, enabling them to gain diverse industry experience while contributing to bringing safe and effective medicines to global markets.
