Sr. Manager - Pharma - Regulatory Affairs USA/ EU Market Goregaon

You will be responsible for,

1. Candidate will be based at corporate office of reputed pharma company at Mumbai and will handle & coordinate with all Regulatory Affairs functions related to plant, R&D International Business of company also for export to USA, EU, Emerging Market.

2. Prepare registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. This would entail thorough familiarity with FDA, & FSSAI online portal, Drug Act and its various Schedules.

3. Co-ordinate with QA and R&D departments for technical documents (manufacturing documents like batch records, specifications, analytical methods, validation reports, and Stability data) required to be incorporated in the registration dossiers.

4. Candidate will be responsible for to obtain additional product permissions, test license, Certificates.

5. Candidate will be responsible for to submit the required information to regulatory authorities.

6. Candidate will be responsible for obtain product permissions, test license, plan approval, etc

7. Candidate will be responsible for good knowledge of GxPs (GMPs, GLPs, GCPs), UCPMP, DPCO and other standards applicable to pharma, food and cosmetic industry products.

Required Candidate profile

1. Candidate should be B. Pharma / M. Pharma / with minimum to 12 to 15 years experience in reputed Pharma Formulation Regulatory Affairs plant, R&D International Business of company also for export to USA, EU, and Emerging Market.

2. You should be good in preparation & review of product registration/renewal of dossiers (D & C Act) for Regulated markets.

3. You should have good knowledge of GxPs (GMPs, GLPs, GCPs), UCPMP, DPCO and other standards applicable to pharm, food and cosmetic industry products

4. You should be good in to check the artworks for compliance with regulatory and pharmacopoeia requirements of products.

5. You should be good in to ensure regulatory compliance as per D&C Act and Marketing authorizations