Regulatory Affairs Manager

AM / Manager- Regulatory

Location: Worli - Prabhadevi, Mumbai

Designation: AM / Manager- Regulatory

PURPOSE OF THE POSITION:

To compile and submit the dossiers for APAC, ROW, LATAM markets.

Preparation of dossiers is mandatory. Candidate having experience in preparation and also in the above markets. Kindly share your profiles.

REQUIREMENT PROFILE:

Qualification: M. Pharm

No of year’s exp: 6-8 years

MAJOR RESPONSIBILITIES:

• Coordination with internal and external parties for regulatory filing related documentation

Review of plant and R&D documents.

• Planning and preparation for Renewals / annual maintenance/PSUR/PC of MAs assigned. Plan

and priorities variation submissions & artwork implementation based on nature/ criticality of

change. Review and correct packages within a team before submission to the respective authority.

• Compilation of Dossiers, post approval changes, queries, Tender documents.

• Collaborated with cross-functional teams to ensure regulatory compliance.

• Maintained accurate records of regulatory submissions and communications

• To register new products in various countries and replying to queries. Co-ordinating with various

departments for collection of samples and documents. Preparation and evaluation of artworks,

Tender Documents, FDA online application.