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.

- Strong 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