Job Summary

Position: RA Executive (Khopoli)

Location: Khopoli - Raigarh

Experience: 5 - 6 Years

Industries: Pharma

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)
Solid understanding of cGMP, ICH, and global registration processes
Valuable command of technical writing and documentation
Excellent coordination and communication skills
Attention to detail and a solid sense of compliance

Required Qualification
B.Pharm/M.Pharm

Key Skills
Regulatory Affairs
Ra

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