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)
- Strong 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 strong sense of compliance

Required Qualification
- B.Pharm/M.Pharm

Key Skills
- Regulatory Affairs
- Ra

📌 RA Executive (Khopoli) (Raigarh)
🏢 Quality HR Services
📍 Raigarh