Regulatory Affairs Associate

Why This Role Matters
This role is critical in ensuring timely regulatory approvals for pharmaceutical products across international markets. By managing submissions, lifecycle activities, and compliance requirements, you directly contribute to product availability, regulatory success, and global expansion of medicines.

Job Description
Sun Pharma is hiring an Executive – Regulatory Affairs for its R&D1 Regulatory Affairs division in Baroda. This role focuses on handling regulatory submissions, dossier preparation, lifecycle management, and compliance for MENA markets, ensuring smooth approvals and adherence to global regulatory standards.

Key Features of the Role:
• Exposure to international regulatory markets (MENA, South Africa)
• Hands-on experience in CMC dossier preparation and submissions
• Involvement in lifecycle management and regulatory strategy
• Cross-functional collaboration with R&D, QA, and manufacturing teams
• Strong foundation for global regulatory affairs career

Responsibilities
• Prepare and review CMC (Chemistry, Manufacturing and Controls) dossiers for new submissions and renewals
• Review development reports, scale-up reports, specifications, stability protocols, and artworks before exhibit batch initiation
• Draft and submit responses to regulatory deficiencies and queries for timely product approvals
• Manage lifecycle activities including variations for API changes, manufacturing site changes, and product harmonization
• Ensure compliance with country-specific regulatory requirements for MENA and South Africa markets
• Prepare and circulate approval packages along with product history sheets to stakeholders
• Maintain accurate regulatory documentation in centralized repositories
• Assess regulatory impact of change controls, variations, and updates

Required Qualifications
• Strong understanding of regulatory submission processes and lifecycle management
• Knowledge of CMC documentation and global regulatory guidelines
• Familiarity with dossier preparation and compliance requirements

Educational Requirements:
• M.Sc or M.Pharm

Experience and Skills:
• 1 to 4 years of experience in Regulatory Affairs
• Experience in handling submissions for international markets preferred
• Good understanding of pharmaceutical development documentation
• Strong attention to detail and documentation skills
• Effective communication and stakeholder coordination abilities
• Ability to manage multiple regulatory projects and timelines

Salary Insights
• Estimated salary range: ₹4 LPA – ₹8 LPA (based on experience and skills)

Company Overview
Sun Pharma is one of the largest pharmaceutical companies in India and a global leader in specialty generics. The company operates across multiple international markets, delivering high-quality, affordable medicines while maintaining strong regulatory and compliance standards.

FAQs
• What markets will I work on?
Primarily MENA regions and South Africa regulatory markets.

• What type of regulatory work is involved?
CMC dossier preparation, submissions, query responses, and lifecycle management.

• Is prior international regulatory experience required?
Preferred but not mandatory for candidates with strong regulatory fundamentals.

• What is the career path?
Executive RA → Senior Executive → Assistant Manager → Regulatory Affairs Manager

Application Tips
• Highlight your experience in CMC dossier preparation and submissions
• Mention any exposure to international markets (MENA, US, EU, etc.)
• Showcase your role in handling regulatory queries and lifecycle management
• Emphasize documentation accuracy and compliance knowledge
• Include examples of cross-functional collaboration with R&D or QA teams