RA Executive (Khopoli)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 15 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:- :- Upto 7.00 LPA
If you are interested for this opening please send updated resume on or revert on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
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