Fulltime Senior Regulatory Affairs Associate (Netherlands or Belgium)
- Antareslaan 41, 2132 JE Hoofddorp, Netherlands
For one of our external clients, we are looking for an experienced regulatory affairs associate who is a Dutch native speaker. At this CRO, they work every day to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do. Are you our newest colleague in Regulatory Study Start-Up?
The office location is in Amsterdam (The Netherlands) or Wavre (Belgium).
You will act as a Regulatory Project Lead on assigned clinical research projects. As part of a multi-national project team, you will take the lead to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOPs). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.
Scope of responsibilities
- To prepare and coordinate of regulatory deliverables for assigned projects in the Netherlands and other countries, including close cooperation with regulatory authorities.
- To act as local regulatory contact and regulatory lead for assigned studies.
- Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.
- Working under the general direction of the CTRS Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time.
- Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs.
- Preparation and review of drug labels to ensure compliance with GMP Annex 13 and national requirements.
- May prepare and/ or deliver a presentation with the support of senior colleagues.
- Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope.
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
- Several years’ experience (3-5 years') in an industry-related environment (CRO or pharma companies)
- Experience in Regulatory and/or Ethics Committee submissions for Clinical Trials in the Netherlands and Belgium.
- Dutch native speaker, at least fluent vocal and written English, French language would be a plus.
- Result oriented
- Interpersonal communication skills
- Team player: teamwork and collaboration
- Solving business problems
We are also open for starters who would like to develop themselves in this direction. If no experience, a strong motivation to develop further into a (regulatory) project management role and consultancy, however must meet the applicable education requirement.