RA Executive (Khopoli)

Job Summary Responsibilities

• Dossier Preparation Submission
• Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets.
• Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations.
• Ensure accuracy and completeness of Module 1;5 in line with specific regulatory authority requirements.
• Regulatory Compliance Communication
• Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines.
• Review and submit annual reports, amendments, variations, and renewals as required.
• Communicate with regulatory agencies and address queries, deficiencies, and clarifications (QA) in a timely manner.
• Documentation Data Collection
• Coordinate with RD, QA, QC, Production, and Supply Chain teams to gather necessary technical documents.
• Maintain and update regulatory databases, trackers, and registration status reports.
• Change Control Lifecycle Management
• Evaluate regulatory impact of change controls and ensure timely submission of variations.
• Support post-approval submissions and product updates in different markets.
• Audit Inspection Support
• Provide regulatory support during internal and external audits (e.g., USFDA, MHRA, WHO-GMP).
• Maintain audit-ready regulatory documentation.

Required Skills

• In-depth knowledge of regulatory guidelines (USFDA, EMA, MHRA, WHO, TGA, CDSCO)
• Experience in dossier preparation and submission formats (CTD, eCTD, ACTD)
• Strong understanding of cGMP, ICH, and global registration processes
• Good command of technical writing and documentation
• Excellent coordination and communication skills
• Attention to detail and a strong sense of compliance

Required Qualification

• B.Pharm/M.Pharm

Key Skills

• Regulatory Affairs
• Ra