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 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.
• Minimum Work Experience:
Several years’ experience in an industry-related environment (CRO or pharma companies)
• Language Skills:
Dutch native speaker, at least fluent vocal and written English, French language would be a plus.
• Results Orientation
• Interpersonal Communication
• Teamwork & Collaboration
• Solving Business Problems