Regulatory Affairs Manager

Sun Pharmaceutical Industries is India's largest pharmaceutical company and the world's fourth-largest specialty generic pharmaceutical company. With a global presence in over 100 countries, Sun Pharma is committed to providing affordable and innovative medicines to patients worldwide.

We are seeking an experienced Regulatory Affairs Manager to lead regulatory submissions, product registrations, and compliance activities for our formulations portfolio. This role involves managing interactions with CDSCO, USFDA, and other global regulatory authorities to ensure timely product approvals.

• Lead preparation and submission of regulatory dossiers (ANDA, NDA, DMF) for domestic and international markets
• Manage product registration processes with CDSCO, USFDA, EMA, and other regulatory authorities
• Ensure compliance with regulatory guidelines, GMP standards, and pharmacovigilance requirements
• Coordinate with R&D, manufacturing, and quality teams for regulatory documentation and queries
• Monitor regulatory changes and assess impact on product portfolio and business strategies
• Represent the company in regulatory inspections, audits, and meetings with health authorities

• Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's or PhD preferred
• Minimum 7 years of experience in regulatory affairs in the pharmaceutical industry
• Strong knowledge of CDSCO, USFDA, ICH guidelines, and global regulatory frameworks
• Proven experience in managing ANDA/NDA submissions and product life cycle management
• Excellent documentation, analytical, and project management skills
• Strong communication skills for effective liaison with regulatory authorities
• Experience with regulatory database systems and electronic submissions

• Competitive package between ₹15L – ₹20L per annum
• Work with India's largest pharmaceutical company on global regulatory strategies
• Contribute to making life-saving medicines accessible to patients worldwide
• Stable career opportunity with comprehensive health and retirement benefits
• Continuous learning through regulatory training programs and conferences

This opening is not listed on any public job portal. It is a verified internal opportunity exclusively accessible through the website careerjump.co.in and directly apply to this job role. They also have similar job openings posted daily on their website. You can also join their WhatsApp Community for daily updates on verified internal job openings.