Do you want to contribute to the availability and safety of innovative pharmaceutical products in an international and dynamic environment? Do you enjoy working in a collaborative team with opportunities for growth and development? This could be your next challenge!
Job Description
We are looking for a Regulatory Affairs Specialist who will be responsible for the end-to-end regulatory management of a portfolio of pharmaceutical products, including the preparation, submission, and maintenance of licensing dossiers.
You will ensure that variations, renewals, and other regulatory changes are executed efficiently, compliant with regulations, and in line with corporate timelines. This role requires strong knowledge of regulatory processes and procedures, and the ability to liaise effectively with internal stakeholders and regulatory authorities.
The scope covers a large portfolio of products, requiring careful coordination and strategic oversight to ensure continued compliance and market availability.
Responsibilities
- Manage licensing-related activities for a defined product portfolio, including variations, renewals, and other dossier updates.
- Coordinate submissions to competent authorities and follow up on timelines.
- Maintain knowledge of relevant regulatory requirements and guidance.
- Serve as main contact point for regulatory queries within the assigned portfolio.
- Work closely with internal colleagues, including regulatory specialists and product managers, to ensure smooth implementation of dossier updates.
- Support the development of regulatory strategies for the product portfolio.
Profile
- Bachelor's or Master's degree in Veterinary Medicine, (Bio)Chemistry, Biology, Biomedical Sciences or a related discipline.
- Minimum of 3-5 years' experience in Regulatory Affairs within the pharmaceutical or veterinary sector.
- Strong knowledge of regulatory processes and dossier maintenance.
- Excellent communication skills in English, both written and spoken.
- Strong organisational skills with an eye for detail.
- Ability to work independently and in a team, under pressure.
- Flexible, proactive, and service-oriented.
What we offer
- Contract: Until February 2026.
- Hours: 40 hours per week.
- Location: Boxmeer, Netherlands.
- Freelance: Opportunities for freelance engagement can be discussed.
- Salary: €4,500 - €6,000 per month, depending on experience.
- Vacancy Reference: 26585.
