Regulatory Affairs Manager

Regulatory Professionals ,
Marlow, Buckinghamshire
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Overview

Role: Regulatory Affairs Manager Location: Galashiels or Marlow Employment: Permanent, Full Time Salary: competitive benefit package Reference number: Company Our client is a Japanese pharmaceutical and biotechnology company who develops innovative specialty drugs, to raise the health and well-being of people around the world. This position will support regulatory activities associated with EU post-licensing activities and development, including development of regulatory strategy and regulatory activities for clinical trials. This position would suit an individual with sound EU pre and post-licensing regulatory experience in particular with centralised products Main responsibilities Manage compliance with relevant regulatory legislation and guidelines Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice Implementation of the regulatory activities required by the terms of the marketing authorisations and driven by business need Provision of information requested by regulatory authorities Manage communications with regulatory authorities and internal stakeholders Knowledge, Experience & Skills: Eligibility to work in the UK Strong centralized procedure and Orphan drug knowledge/experience Extensive experience in clinical trial applications Good regulatory knowledge with a proactive approach Strong work ethic If you are interested in discussing this role further, then please email your CV to or call Amani on 01189 522 797 to arrange a confidential discussion. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers terms and conditions apply. This job was originally posted as www.totaljobs.com/job/89944451

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