The Regulatory Affairs Officer will oversee and optimize regulatory affairs (development, registration, maintenance) for the portfolio of products registered in the Netherlands, in accordance with regulatory requirements, group procedures, and strategies.
Key Responsibilities:
- Manage direct interactions with local regulatory authorities
- Submit applications to national authorities
- Provide local support to the EU Regulatory Department
- Monitor submission and follow up with local authorities
- Prepare risk minimization measures and educational materials
- Review artworks and follow artwork implementation
Skills & Experience Required:
- University Degree in Life Science
- Experience in the field of Regulatory Affairs in the pharmaceutical industry, and be familiar with the MEB and registration procedures.
- Strong knowledge and understanding of EU regulatory compliance requirements.
- Strong knowledge and understanding of Regulatory Affairs principles, concepts, and standards.
- Strong knowledge and understanding of local NL regulations.
- Highly proficient in both spoken and written English and Dutch;
- Ability to set priorities and keep structure/organization;
- Work accurately and have an eye for detail;
- Communicate clearly and proactively;
- Ability to multi-task in a fast-paced environment;
- Experience using computerized systems (PC-Windows and Pack-Office).
