Your main focus will be regulatory activities at Benelux level.
Depending on your level of experience, you will, for our clients:
- Manage or support a product portfolio and interact with national competent authorities on regulatory submissions in Benelux countries.
- Support the European regulatory affairs groups with local regulatory intelligence information and contribute as appropriate to the regulatory strategies.
- Interact with colleagues from European headquarters at client companies with regard to the collection of information necessary for submissions and to address questions from competent authorities.
- Be responsible for, or assist with, the preparation, submission and follow-up of marketing authorization applications and variation files, in line with national Benelux regulatory requirements, scientific principles, and company policies and procedures.
- Assess material for publicity and information purposes and compliance of scientific/commercial events in the Benelux territories.
- Contribute to the maintenance of quality systems and SOP writing.
- Master in Pharmaceutical Sciences or equivalent with minimum 3 years of experience in Benelux regulatory affairs.
- Experience with review and approval of publicity and medical information is an asset.
- Proficient oral and written Dutch, French and English language skills; German is a plus.
- Ability to foster relationships with internal and external stakeholders (such as RA colleagues, medical affairs, commercial, market access, pharmacovigilance, and competent authorities).
- Diligent to work in compliance with regulatory legislation and Quality Assurance systems.
- Ability to adapt to different client company cultures and service minded attitude.
- Accurate, proactive, reliable, hands-on, and quality output driven.
- Maintain product portfolio overview, proven ability to meet deadlines and set priorities.
- Positive and pleasant personality with effective interpersonal skills.
- A competitive salary.
- Varied job in a young and dynamic environment.
- Continuous learning and exchange of expertise with seasoned regulatory affairs colleagues.