Your main focus will be regulatory activities at EU level. Embedded in and supported by our team, you will support our clients with more complex assignments such as developing sound regulatory strategies, support and lead submissions of orphan drug designations, pediatric investigation plans and scientific advices. You may also be assigned to submission of new marketing authorization applications and the maintenance of existing marketing authorization applications and contribute to clinical trial applications and the related submission strategy. You may participate in client project teams in an international environment.
- Master or PhD in a scientific discipline relevant to the development and life cycle management of medicinal products.
- At least 5 and ideally 7-15 years of experience in medicinal product development and life cycle management including at least 5 years of experience in European or global Regulatory Affairs.
- Strong scientific background. Experience in specialized areas of medicinal product development such as biologicals, infectious diseases, oncology, immunology or other is a plus.
- Seasoned in EU regulatory affairs of medicinal products. Exposure to devices/IVD is a plus.
- Successful track record in liaising with regulatory authorities.
- Excellent language skills in English, Dutch - French is a plus.
- Clear and effective written and oral communication skills // Strong analytical and problem solving skills.
- Good project management skills.
- Proactive and “can do” attitude.
- Customer minded and quality output driven.
- A highly motivated, dynamic person and team player who can operate in a flexible and often virtual working environment.
- Pleasant personality with effective interpersonal skills.
- A competitive salary.
- Varied job in a young and dynamic environment.
- Exchange of expertise with seasoned regulatory affairs colleagues, passionate about regulatory affairs.
If you are looking for a new challenge in contributing to medicinal product development and registration supporting both major pharmaceutical companies and Biotech SMEs, eventually fulfilling the unmet need of patients, and if you share our passion for regulatory affairs, consider becoming part of our team.