India Regulatory Affairs Manager Position at Sun Pharma-Apply before 31st March 2025

About Sun Pharma

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth-largest specialty generic pharmaceutical company globally, with annual revenues exceeding USD 5.8 billion. With over 40 manufacturing facilities worldwide, we deliver high-quality, affordable medicines trusted by healthcare professionals and patients in more than 100 countries.

Position: Manager – India Regulatory Affairs (IRA)

Department: India Regulatory Affairs

Key Responsibilities:

• Develop and evaluate regulatory strategies for product registrations in India.
• Submit applications on the online portal for domestic manufacturing and marketing permissions from the DCGI.
• Handle applications for import registration and import licenses for drugs and medical devices in India.
• Assess required documentation and coordinate with relevant teams for finalization.
• Submit applications for Bioequivalence (BE) permission required for export registration.
• Process applications for manufacturing drugs for examination, test, or analysis (Form CT-10/12/13).
• Submit applications for drug import permissions for examination, test, or analysis (Form-11/Form CT-17).
• Handle applications for import drug permissions under Form 8.
• Manage applications for importing medical devices for examination, test, and analysis (MD-16).
• Review draft Gazette notifications related to regulatory affairs and provide comments.
• Address regulatory authority inquiries and respond to market complaints.

Candidate Requirements:

• Experience: 5-10 years in Regulatory Affairs
• Qualification: M.Pharm
• Location: Tandalja, Gujarat
• Industry: Pharma / Healthcare / Clinical Research
• Functional Area: Regulatory Affairs

📅 Application Deadline: 31st March 2025

Join India’s No. 1 Pharmaceutical Company and be part of our mission to make quality medications accessible to all. Apply now! 🚀