Regulatory Affairs Specialist | Benelux
The Regulatory Affairs Specialist is responsible for implementing complex regulatory strategies, obtaining and maintaining marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of the companies’ products in the Benelux region. Serves as a consultant to managers and will manage several product launches per year.
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
- Provide regulatory advice to project teams.
- Provide guidance and coaching for areas of responsibility to lower level team members.
- Respond to regulatory authorities’ questions with strict deadlines
- Develop and initiate complex regulatory project plans
- Maintain and update existing regulatory authorizations
- Lead or represent Regulatory Affairs in project teams
- Review promotional material for compliance with local regulations
- Pharmacist or Medical Doctor
- Fluency in French, Dutch and English is a must
- Minimal 3 experience in RA or equivalent experience within a pharmaceutical company CRO, or similar organization
- Ability to work under minimal supervision
- Strong negotiation skills
- Technical system skills
- Ability to manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary