Regulatory Affairs Specialist at Sun Pharma – Baroda

Location: Baroda, India

Position: Regulatory Affairs Specialist

Qualification: M.Pharm

Experience: 2-5 years

Job Description:

Sun Pharma is seeking a Regulatory Affairs Specialist to join our team in Baroda. The successful candidate will be responsible for:

• Reviewing all data and documents related to product registrations for various health authorities.
• Compiling registration dossiers for submission to health authorities such as US-FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.
• Preparing responses to deficiency letters received from various agencies.
• Maintaining life-cycle/post-approval changes for drug product registration dossiers.
• Providing regulatory support to cross-functional departments.
• Preparing and submitting scientific advice to various health authorities.
• Compiling, verifying, and submitting eCTD through electronic gateways.

How to Apply:

Interested candidates are invited to send their resumes to Hr.tandalja@sunpharma.com.