Sr. Manager-Regulatory Medical Writing - Submission Expert

Role & Responsibilities
• Author, manage and lead development of regulatory medical writing documents for global and domestic submissions
• Prepare protocols, clinical study reports, investigator brochures, briefing documents, IND/NDA/MAA and regulatory response documents
• Collect, evaluate and integrate cross-functional scientific data into showing cohesive submission strategies
• Plan, outline, write, review, coordinate approvals and finalize regulatory documents
• Conduct document initiation and comment-resolution meetings for stakeholder alignment
• Ensure accuracy, consistency and scientific integrity across related documents
• Perform quality checks, peer reviews and maintain audit-ready documentation
• Coordinate scientific reviews and manage timelines and delivery risks
• Maintain therapeutic area knowledge and regulatory guideline updates
• Provide coaching, support metrics tracking and contribute to process improvements
• Maintain training records and support vendor coordination when required

Qualification
• Doctoral or Post-Graduate degree in Life Sciences / Pharmacy or clinical degrees (MBBS / BDS / BAMS / BHMS etc.)
• Advanced degree (MD / PhD) preferred

Experience
• Minimum 3+ years of experience in regulatory medical writing with leadership exposure

Skills
• Strong knowledge of ICH, global regulatory guidelines and pharma industry standards
• Excellent scientific writing, documentation and editing skills
• Strong project management, decision-making and risk-mitigation abilities
• Excellent communication, stakeholder management and interpersonal skills
• Innovative, detail-oriented and adaptable working approach

About the Company
Sun Pharmaceutical Industries Ltd (SPIL) is India’s largest pharmaceutical company and a leading global specialty generics organization with a strong R&D-driven culture delivering high-quality, affordable medicines across more than 100 countries.