1 Opening(s)
6.0 Year(s) To 7.0 Year(s)
6.00 LPA TO 7.00 LPA
Job Description: Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations.
? Preparation, Compilation & Review of Registration documents that include Administrative & Technical.
? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
3.00 LPA TO 3.60 LPA
Job profile.
1. Dossier preparation and filling for product registration in International Regulatory bodies.
2. Query replies to International regulatory authority for the dossier for product registration.
3. Documents follow up with Production,QA and QC dept required for Dossier preparation.
4. Regulatory Samples follow up for the product registration along with dossiers filling.
5. Product finalization with clients as per ...
1 Opening(s)
3.0 Year(s) To 5.0 Year(s)
2.50 LPA TO 3.60 LPA
Regulatory Affairs Officer (RA)
Qualification: B.Pharm/ M.Pharm
Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience.
Job Description:
Preparing dossiers as per country-specific guidelines.
Compiling and reviewing documents.
Coordinating with QA for documentation.
Addressing queries raised by respective countries' FDA.
Bond: 18-month ...