Responsibilities of the Support Regulatory Affairs activities in the EU region
- Providing regulatory support in preparation of the submission and during the review of variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
- Completing and organizing the gathering of the module 1 components.
- Collaborating closely with national Agencies in order to ensure timely approval by national Agencies.
- Ensuring updates to regulatory databases.
- Keep up to date with EU procedural requirements and legislation.
Profile of the Support Regulatory Affairs activities in the EU region
- Must be hold a MS degree in pharmacy or other life science
- Minimum of 2 year s experience in the Regulatory Affairs (human medicinal products).
- Knowledge of EU and national regulatory procedures and development of medicinal products in general is preferred.
- Good organizational skills, proven ability to multi-task.
- Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.
- Demonstrates the ability to review regulatory documents for accuracy.
- Understands the end-to-end pharmaceutical lifecycle.
- Excellent written and verbal communication skills in French or Dutch (native) and English.
Offer for the Support Regulatory Affairs activities in the EU region
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees