freelance
Regulatory Affairs Manager Reference number: 1168
Last update: 25-10-2019, 13:48
Region: Braine L'Alleud
Sector: Pharmaceutical
Work experience: 2-5 years hands-on experience with Clinical Trial Applications in EU
Job description
Our client is looking for a Regulatory Affairs Manager to coordinate clinical trial submission and follow-up activities for Cimzia and bimekizumab.
Manage Clinical Trial Applications (CTA’s) in EU and provide operational regulatory support and guidance in cross-functional clinical trial teams (internal and external).
Manage clinical trial submissions to agreed project targets, and oversee the work of the assigned Contract Research Organization (CRO).
Work flexibly within the EU team to provide broad operational for initial clinical trial applications, Q&A with Authorities/Ethics Committees, study maintenance, amendments, trial closure activities and archiving of trial documents.

The ideal candidate also has experience with assisting in the review and preparation of protocol/IB/IMPD and other CTA documents.
What you’ll do
  • Support the EU Regulatory Science Lead (RSL) and assist in the planning, preparation and delivery for the delivery of timely Clinical Trial Applications and approvals, in compliance with relevant procedures and regional/local country regulations.
  • Represent the EU Regulatory team in cross-functional workstreams to provide regulatory expertise on clinical trial submissions, and liaise proactively with the functions and participate as a member of cross-functional delivery teams (internal and external)
  • Ensure that appropriate, up-to-date records are maintained for compliance in the client's document management systems
Profile
  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Effective communication skills
  • Flexibility and adaptability - decides what to do based on the situation. Works effectively in ambiguous situations.
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Organizational Skills
  • Integrity – overriding commitment to integrity and high standards in self and other
Required Skills
  • The ideal candidate has 2-5 years hands-on experience with Clinical Trial Applications in EU, with knowledge of assigned regional regulatory procedures and legislation
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