Reference Number: JO-2003-448112
Regulatory Affairs Manager
Rate: Negotiable
Job Type: Permanent
Location: Marlow

Role: Regulatory Affairs Manager
Location: Galashiels or Marlow
Employment: Permanent, Full Time
Salary: competitive + benefit package
Reference number:

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 amani.yousef@regulatoryprofessionals.com or call Amani on 01189 522 797 to arrange a confidential discussion.

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