RA Executive (Khopoli)

Job Description:

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 (Q&A) in a timely manner.
• Documentation & Data Collection
• Coordinate with R&D, 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

Salary :- Upto 7.00 LPA

If you are interested for this opening please send updated resume on cv@qualityhr.co.in or revert on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-