Pharmacist
About the Role
Roles & Responsibilities
• Assist in preparation of CTD / ACTD / eCTD dossiers for domestic and ROW markets
• Support timely and error-free regulatory submissions
• Help evaluate and respond to health authority queries
• Assist in filing post-approval variations under regulatory guidelines
• Review technical documents such as Process Validation, AMV, Stability Data, PDR, and CDP
• Coordinate with HO, Plant, QA, and R&D teams to collect documents and samples
• Support development and review of product artworks for registration and commercial compliance
• Maintain and update regulatory database, tracking documents, registrations, and RLD samples
• Handle administrative documentation including Product Permissions, COPPs, and FSCs
Qualification
• (Bachelor's degree in Pharmacy) B.Pharm or (Master's degree in Pharmacy) M.Pharm
Experience
• Fresher or 1–2 years of experience in Regulatory Affairs
Skills
• Good documentation and coordination abilities
• Basic understanding of regulatory frameworks
• Effective communication and teamwork skills
• Attention to detail and ability to follow processes
About the Company
Encore Group is a Mumbai-based pharmaceutical company focused on delivering high-quality healthcare products in domestic and international markets. The company promotes innovation, compliance, and collaborative teamwork to support regulatory success and global product availability.
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