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 solid 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
[email protected] or revert o
📌 RA Executive (Raigarh)
🏢 Quality HR India
📍 Raigarh