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Regulatory Affairs ManagerRef: TJBMAN1507

Salary:€50.00 - €70.00 per hour

Added:13 Feb 2020

Region: Europe

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

Main Responsibilities: - As a member of the Regulatory Strategy & Intelligence team you will contribute to the action plan to implement ISO IDMP standards within the company - Contribute to the company System Delivery and Data Migration Workstreams to ensure activities are on-track and meet IDMP requirements in the new RIM system - Contribute to the review of draft ISO IDMP requirements/guidance documents with internal alignment - Support process changes at global and local levels to ensure compliance with HA requirements (planning, compilation, publishing and submissions to HAs according to the right format) - Work with external Business Consultancy according to company needs Candidate Profile: - Education: Life Science Degree (e.g. Chemistry, Pharmacy, Biology), or MBA (Project Management) - Languages: Fluency in English as a business language. Additional language is an asset - Professional experience: * 3-5 years of experience in Regulatory submissions in Europe (post-marketing experience in CMC, Labeling variations, xEVMPD) * 3-5 years of experience in Project management and Submission management * Experience in using RIM systems and publishing related software/tools * Good knowledge of the drug development process and submission guidelines * Good knowledge of publishing processes. For further details about this role, or to discuss other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email

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