Job Objective
Dossier Review and submission for EAEU markets.
Product Life Cycle Management - Handling responses to Queries, Product Renewals and Post approval Changes (Variations).
Address the regulatory queries.
Site related audits and regulatory compliance.

Primary Responsibilities
Responsible for review and submission of dossiers for product registration in the EAEU region.
Response of queries and other requirements as required by respective regulatory authorities in a stipulated time frame.
Support Product Life Cycle Management activities.
Support in reviewing of ASMF's/DMF, R&D; data & plant data.
Responsible for Product Information review & approval of Artworks/Mock-ups.
Coordinate with R&D; and Plant teams to ensure proper documentation as per regulatory requirements.
Responsible for administrative documents & legalisation (Test License, Manufacturing License, WHO GMP, GMP, COPP, FSC etc.).
Responsible for handling product renewals of commercialized products for maintaining registration validity.
Coordinating with various departments such as Manufacturing, Product Development, QA, QC, R&D;, Legal etc.



to ensure availability of documents and samples for submission.
Responsible for samples and analytical standards sent to agencies for pharma expertise as part of the registration process.

Skills/Competency Required:

Functional
Positive knowledge of country regulations & guidelines.
Robust analytical and problem-solving skills.
Expertise in documentation and technical review.

Key Performance Areas:
Regulatory on-time registration/submission.
Query Response Preparation &
Review.
Product Renewals and Post Approval Changes (Variations).
Technical Review of API - ASMF/DMF &
Plant and R&D; data.
Problem solving/coordinating with CFTs for development & manufacturing.
Support in client management for regulatory registrations for EAEU and emerging markets.
Preparation &
Review of Product Information &
Artworks/Mock-ups.
Preparation & ensuring administrative documents & legalisation (Test License, Manufacturing License, WHO GMP, GMP, COPP, FSC etc.)

📌 Regulator Affairs Eaeu Hyderabad
🏢 Jodas Expoim
📍 Hyderabad