Sun Pharma Announces Regulatory Affairs Job Opening | Apply Today
Looking for a Regulatory Affairs Job with one of India’s leading pharmaceutical companies? Sun Pharma Careers has announced an excellent opportunity for an Executive – Regulatory Affairs at its Baroda R&D facility. This opening is ideal for M.Pharm candidates with 1–4 years of experience who have expertise in USFDA regulations, ICH guidelines, CTD/eCTD submissions, and global regulatory compliance. Explore the complete job details, eligibility criteria, responsibilities, qualifications, and application process below to take the next step in your pharma career.
- Job Title: Executive – RA
- Location: Tandalja – R&D
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A – Executive
About the Company
Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and one of the world’s leading specialty generic pharmaceutical organizations. Through Sun Pharma Careers, the company offers professionals opportunities to work on innovative research, regulatory excellence, quality compliance, and global healthcare solutions. Employees are encouraged to grow professionally while contributing to life-changing medicines for patients across the globe.
Job Description
Sun Pharma is hiring an Executive – Regulatory Affairs to manage regulatory submissions, ensure compliance with USFDA and ICH guidelines, prepare CTD/eCTD dossiers, coordinate with cross-functional teams, respond to regulatory authority queries, and support global regulatory strategies for pharmaceutical products. This role is ideal for M.Pharm professionals with 1–4 years of Regulatory Affairs experience.
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.
- Monitor changes in global regulatory guidelines and communicate the impact to stakeholders.
- 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 approval.
Qualification
- M. Pharm
- Experience: Tenure: 1 – 4 Yrs.
