Sun Pharma looking for Senior Manager - Regulatory & Business Continuity

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Senior Manager - 2

Job Description
Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.

Area of Responsibility
1. New submissions:
• Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
• Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.
2. Approval :
• Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
3.Lifecycle management for drug formulations:
• Prepare and review variation, Annual notification and labelling approval for US and OAM
• Review of change control and file variation as per country requirement
4. Regulatory compliance:
• eCTD compilation
• Ensure reposition of comprehensive product information into central repository
• Review regulatory filing impact of variations, change controls, etc.

Competencies Required :
• Experience of USFDA market.
• Knowledge of CMC Module-1,2 & 3.
• CMC Dossier Preparation
• Lifecycle Management
• Cross-Functional Collaboration

Additional Information
Experience : 13-18 Years
Qualification : M.Pharm
Location : Gurgaon - R&D
Business Unit : Regulatory & Business Continuity
Job Grade : G9B
End Date : 25th November 2026