Details of the requirement are given below for your reference:
1) Company : Pharmaceutical Industry
2) Position : Regulatory Affairs Manager
3) Experience Required : 10 to 15 Years
4) Salary Negotiable : Salary - Rs. 80,000 PM to 1,00,000 PM Depending upon candidates knowledge
5) Job Location : Ahmedabad
6) Job Description :
Qualification :- B.Pharm/M.Pharm
1. Preparation, Compilation and Review of CTD/ACTD/Country specific dossiers for
regulatory submission including new product Registration/Re-registration of
pharmaceutical products for achieving the successful marketing authorization in
exporting countries.
2. Preparation and Submission of renewal application of registered products as per
regulatory guideline.
3. Preparation and Submission of variation application of registered products as per
regulatory guideline.
4. Review registration and re-registration dossier.
5. Handling queries received from the different ministries and Tracking of query
received from country and answer within stipulated time to country.
6. Co-ordination, collection and Review of necessary information/data from F&D,
QA, QC and Store department for registration requirement as well as update
registration information to respective department.
7. Prepare, Review and co-ordinate for FDA and DCGI related activities like
Manufacturing License, WHO COMP, Product permission, COPP, Approval of
Technical Person, Free sale certificate etc.
8. Handling of GMP documents like Change Control.
9. Review artwork for commercial and registration purpose.
10. Review DMF (Drug Master File) and Co-ordinate with
manufacturer/purchase for regulatory compliance.
11. Maintain and Update registration status time to time.
12. Maintain regulatory activity going on country, follow up for pending activity.
Interested candidates can apply immediately.
With Regards,
Gopi (HR)
7777981971
Pay: ₹80,000.00 - ₹100,000.00 per month
Work Location: In person
