Officer - Regulatory Affairs

Roles & Responsibilities
• Prepare CTD / ACTD / eCTD dossiers for domestic and ROW markets
• Ensure timely and error-free regulatory submissions in country-specific formats
• Evaluate and respond to health authority queries and customer-specific regulatory requirements
• File post-approval variations in compliance with regulatory guidelines
• Review technical documents including Process Validation, AMV, Stability Data, PDR, and CDP for alignment with dossier requirements
• Coordinate with HO, Plant, QA, and R&D teams to collect documents and samples for registration
• Develop and review product artworks ensuring compliance for registration and commercial use
• Maintain and update regulatory database, tracking manufacturing, quality documents, registrations, and RLD samples
• Manage administrative documentation such as Product Permissions, COPPs, and FSCs

Qualification
• M.Pharm (Master's degree in Pharmacy) or B.Pharm (Bachelor's degree in Pharmacy)

Experience
• Minimum 2 years of experience in Regulatory Affairs
• Hands-on experience with CTD/eCTD submissions
• Knowledge of ROW market regulations

Skills
• Strong documentation and coordination abilities
• Knowledge of regulatory frameworks for domestic and international markets
• Effective cross-functional communication skills
• Attention to detail and ability to meet submission timelines

About the Company
Encore Group is a leading pharmaceutical company with headquarters in Mumbai, focused on delivering quality healthcare products across domestic and international markets. The organization emphasizes regulatory compliance, innovation, and cross-functional collaboration to ensure timely approvals and product availability globally.