Regulator affairs EAEU

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:

• Good 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.)