Posted:2 days ago|
Platform:
Work from Office
Full Time
To support and execute end-to-end regulatory documentation and review for site transfer projects, from data collation to submission. Key Responsibilities: Coordinate data collection from CFTs for pre submission and site transfer packages. Review all plant-related documents Prepare and submit dossiers for product registrations in Europe, US, UK, Canada, Australia, Brazil markets, ensuring adherence to country-specific guidelines and requirements. Prepare and maintain regulatory trackers. Support query responses and internal audits related to site transfers. Ensure documentation quality and compliance with ICH/FDA/EU/Health Canada guidelines. Qualifications: M. Pharm with 48 years of RA experience. Hands-on in Module 3, eCTD components, and lifecycle submissions. Familiarity with change management systems (Trackwise or similar).
BDR Pharmaceuticals
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