Regulatory Affairs Manager - Pharmaceutical Formulations

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

We are seeking a Regulatory Affairs Manager to lead regulatory submissions and approvals for pharmaceutical formulations across international markets. This role requires expertise in global regulatory frameworks and ability to navigate complex approval processes.

• Lead regulatory strategy and submissions for new drug applications in US, EU, and emerging markets
• Prepare and review comprehensive dossiers including CTD/eCTD formats ensuring compliance with regulatory requirements
• Coordinate with cross-functional teams including R&D, manufacturing, quality, and legal for regulatory filings
• Manage interactions with regulatory authorities including addressing queries and defending submissions
• Monitor global regulatory landscape and communicate impact of regulatory changes to internal stakeholders
• Ensure post-approval compliance including variation submissions, renewals, and pharmacovigilance reporting

• 8+ years of regulatory affairs experience in pharmaceutical industry with focus on formulations
• B.Pharm/M.Pharm required; additional certifications in regulatory affairs (RAC) strongly preferred
• Extensive experience with USFDA, EMA, MHRA, and other international regulatory agencies
• In-depth knowledge of ICH guidelines, GMP, and pharmaceutical regulatory frameworks
• Proven track record of successful ANDAs, MAAs, or NDA submissions and approvals
• Strong technical writing skills with attention to detail and ability to compile complex documentation
• Excellent project management and stakeholder coordination capabilities

• Competitive package between ₹15L – ₹20L per annum
• Work with India's largest pharmaceutical company with global regulatory exposure
• Lead critical regulatory initiatives impacting product launches across multiple markets
• On-site role with access to experienced regulatory professionals and continuous learning
• Opportunity to work on diverse therapeutic areas and innovative pharmaceutical products

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