Regulatory Affairs Officer Job in United HR
- United HR Solutions
- 3 to 5 Yrs
- Ahmedabad
- 4 months ago
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Job Description
- Client's Company Profile: Our client is into Import & Export of Pharmaceutical / Medical Device Company (European MNC). The company provides tailored intelligent healthcare solutions based on the latest professional insights, and on decades of experience in Africa. They are head quatered in Europe, having repacking unit in Gandhidham and Corporate office in Ahmedabad Position: Regulatory Affairs Officer Job Location: Bodakdev (Ahmedabad) Reports To: Regulatory Manager Job Profile: The position would be responsible for : 1. Request, follow-ups and obtain product dossier from the manufacturer where applicable. 2. Assess and report deficiencies to the manufacturer and recollect documentation as appropriate, also to escalate internally and report to manager. 3. Prepare and submit registration dossiers as per CTD/Country specific requirement with layout review for submission. 4. Completion and ensure dossiers submission in targeted timeline. 5. Dispatch of registration dossiers to the National Drug Regulatory Authorities (NDRA)/agents as applicable. 6. Actively finding solutions on queries/feedback from NDRA/agent for suppliers having difficulties in meeting the requirement. 7. Request and follow-up on samples required for submission. 8. Status updates on connect Registration and NDRA overview. 9. Coordinate with Company's agents and Country Managers on handling regulatory submission and update on country guidelines. Process the payment for dossier submission. 10. Review of technical documents/dossiers as per country requirement to ensure quality submission with zero query. 11. Response to query received from NDRA on priority. 12. Smooth initiation of renewal/retention process for different countries and ensure timely submission. 13. Filing of variation in different countries as applicable 14. Ensure that database is maintained updated reflecting actual activity, organize meetings and report to manager. 15. Any other duties or assignments as requested by the manager Desired Candidate Profile: Qualification: B.Pharm / M.Pharm Work Experience: 3-5 years of experience in regulatory functions from pharmaceutical organizations.
- Knowledge of ROW market and regulatory experience in medical devices is preferred.
- Updated on various regulatory guidelines on WHO, EU and ICH.
- Ability to maintain a positive attitude under pressure and in stressful situations.
- Good administrative and communication skills.
- Should be able to work within a team.
- Should be well structured and systematic.
- Languages: Good proficiency in English
Employement Category:
Employement Type: Full timeIndustry: Pharma / BiotechRole Category: Quality (QA-QC)Functional Area: Not SpecifiedRole/Responsibilies: Regulatory Affairs Officer Job in United HRContact Details:
Company: United HR SolutionsLocation(s): Ahmedabad+ View Contact
Keyskills: regulatory affairs ctd ra officer
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United HR Solutions
United HR Solutions Pvt. Ltd. (Estd. 1986) focusing mostly in “Executive Search†for Managerial & Top management positions in all disciplines viz Finance, Marketing, Engineering, HR and IT. Maintaining high standards of ethics and fair play has become, our working philosophy, which...
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