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)
- Support on pharmacovigilance and market access activities when required
- 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 firstname.lastname@example.org /email@example.com and tell us a little more about yourself. We will hear from you soon!