Executive / Senior Executive – Regulatory Affairs Job At Sun Pharma
Sun Pharmaceutical Industries Ltd is hiring an Executive / Senior Executive – Regulatory Affairs (US Market) for its Gurgaon R&D location. This Regulatory Affairs Job role focuses on CMC regulatory activities for biologic products, global regulatory strategy alignment, and high-quality regulatory submissions in compliance with US and emerging market requirements. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Executive – RBC (Regulatory Affairs – US Market)
- Location: Gurgaon – R&D
About the Company
Sun Pharmaceutical Industries Ltd encourages continuous progress, leadership, and collaboration. Employees are empowered to become “Better every day,” “Take charge” of their responsibilities, and “Thrive together” in a culture that values teamwork, innovation, and professional growth. This Regulatory Affairs Job role plays a significant role in the company.
Educational Requirements
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M. Pharm
Key Responsibilities
- Support and manage regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for licensed and clinical biologic products
- Provide strategic regulatory input to product development, commercial, and clinical teams
- Ensure regulatory strategy aligns with global Health Authority requirements and timelines
- Coordinate with global manufacturing sites to integrate regulatory strategy and share updates with senior management
- Provide regulatory support for additional CMC projects as required
- Prepare agency consultation packages, briefing books, and presentations, and participate in regulatory agency consultations
- Manage filing activities, including query responses and post-approval changes for global products
- Conduct reviews as per US and EM requirements and communicate additional data needs to Cross-Functional Teams (CFT)
Skills Required
- Strong understanding of CMC regulatory requirements
- Knowledge of US FDA and Emerging Market regulations
- Experience with biologics regulatory submissions
- Regulatory strategy development and execution skills
- Cross-functional coordination and communication abilities
Why This Job Role?
This Regulatory Affairs Job role offers hands-on exposure to global regulatory affairs for biologics within a leading pharmaceutical organization. It provides an opportunity to work closely with health authorities, global manufacturing sites, and cross-functional teams while building a strong career in US market regulatory affairs. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
