Regulatory Affairs Manager

Sun Pharmaceutical Industries Ltd is India's largest pharmaceutical company and the world's fourth-largest specialty generic pharmaceutical company. With presence in over 100 countries, Sun Pharma develops and manufactures a wide range of pharmaceutical formulations and APIs. The company is committed to providing affordable and innovative healthcare solutions globally.

The Regulatory Affairs Manager will be responsible for managing regulatory submissions, approvals, and compliance for pharmaceutical products across multiple markets. This strategic role requires deep expertise in global regulatory frameworks and the ability to navigate complex approval processes.

• Manage regulatory submissions for new drug applications, variations, and renewals across US FDA, EMA, and emerging markets
• Develop regulatory strategies for product launches and lifecycle management initiatives
• Ensure compliance with CDSCO, FDA, EMA, and other international regulatory requirements
• Coordinate with cross-functional teams including R&D, manufacturing, quality, and medical affairs
• Monitor regulatory intelligence and update stakeholders on changes in global regulatory landscape
• Lead regulatory inspections, audits, and responses to health authority queries

• 7+ years of regulatory affairs experience in pharmaceutical industry with exposure to global markets
• Strong knowledge of ICH guidelines, CTD/eCTD formats, and regulatory submission procedures
• Experience managing FDA, EMA, or CDSCO submissions for generics or specialty pharmaceuticals
• Bachelor's degree in Pharmacy, Life Sciences, or related field; postgraduate qualification preferred
• Excellent project management, communication, and stakeholder management skills
• Proficiency in regulatory information management systems and electronic submission tools
• Ability to interpret complex regulations and provide strategic guidance

• Competitive package between ₹18L – ₹24L per annum
• Drive regulatory strategy for a global pharmaceutical leader with diverse product portfolio
• Hybrid work model providing flexibility while maintaining collaborative team environment
• Exposure to complex regulatory scenarios across multiple therapeutic areas and geographies
• Career advancement opportunities in a rapidly growing pharmaceutical organization

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