DRA HEAD – PHARMA

Job Description : DRA HEAD – PHARMA IRELAND Open to International candidates with 20+ years experience ?? European Country Experience is Mandatory. JOB RESPONSIBILITIES Lead end-to-end DRA activities including regulatory strategy, product registrations, dossiers, variations, renewals and post-approval changes. Manage European regulatory submissions and ensure compliance with applicable EU and country-specific regulatory requirements. Lead responses to regulatory queries, deficiency letters and authority observations with effective coordination across QA, QC, R&D, F&D and Manufacturing. Drive regulatory strategy for new products, lifecycle management, technology transfers and international market expansion. Lead and mentor the DRA team while ensuring timely, accurate and compliant regulatory submissions.

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