Lead/Manager Regulatory Affairs

3 - 5 years

3 - 5 Lacs

Posted:4 days ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role

1) Support all documentation and regulatory requirements for international markets

2) Application management with FDA for license

3) Co-ordinate for Export Orders

4) Technical support for Plant / IPQC

Key Responsibilities

1) Product Registration and Company Registration in International Market

2) Applications for domestic & Export licenses to FDA

3) Co-ordination for Export orders

4) Support plant with technical information when needed

Key Activities

1) Documentation for application filing for licenses to FDA

2) Work with FDA/CDSCO as required during the filing of paper work for licenses, etc.

3) Art work approvals

4) Finalizing export orders with regards to packing, packaging materials

5) Vendor selection for printing approved cartons/labels (PM)

6) Product registration in International Marketing & preparing Dossiers for Registration

7) Work with public testing labs

8) Help Plant / IPQC Dept. as need be.

Functional Knowledge / Skills:

  • General

  • Specialized


1) Pharmacology

2) Computer Skills.

3) Knowledge of Computer Applications software.

4) Co-ordination skills and team work.

1) Pharmacy

2) Global trends

3) Various pharmacopeias

4) Pharma management

5) Sound knowledge of hazardous and non hazardous material and its storage condition.

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