Clinical Research Associate Pharma

Senior regulatory affairs consultant

/ Pharma Jobs /

What is your job?

  •  Ensure quality delivery of regulatory activities for the BeNeLux market. Regulatory activities include but are not limited to:
  • Submission of new MAA, life cycle management activities (submission and follow up for variations, renewals, MAH transfer and withdrawal), interaction with health authorities on behalf of Axtalis customers
  • Compilation , or supervision of the compilation of regulatory dossiers in accordance with national requirements
  • Gain regulatory authority approval and manage follow up post-approval activities
  • Provide regulatory support to clients and associate companies
  • Liaise with regulatory authorities as required
  • Provide format and content review/approval of labelling documents (SmPC, PIL and packaging information)
  1. Support on pharmacovigilance and market access activities when required

OTHER ACTIVITIES

  • Assist the RA Director in presales activities
  • Create or review quality documents such as SOPs related to Regulatory affairs or pharmacovigilance activities

Who is the candidate we are looking for?

  • Minimum 1 year experience in a local BeNeLux regulatory affairs role required
  • Bachelor or Master degree in a science related field, or equivalent by experience
  • This experience should include a proven understanding of the regulatory activities to be performed at local level for BeNeLux markets
  • Excellent organisational and interpersonal skills
  • Process orientated with good attention to detail
  • Effective oral and written communication skills 
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • Good English language and grammar skills (written and verbal fluency). Native Dutch or French

 What’s in for you?

  • Ability to join a young and dynamic company where people count and make the difference
  • Opportunity to grow your current skills set in different domains including regulatory and medical affairs, pharmacovigilance and market access
  • Competitive package with possibility to work partially home based

Want to take this challenge?

Send your resume to liske@nuwhi.be /roxane@nuwhi.be and tell us a little more about yourself. We will hear from you soon!