1. Manage all regulatory activities needed to obtain Marketing Authorizations (MAs) and other
authorisations for all medicinal and non-medicinal products (medical devices, food supplements,
cosmetics).
2. Prepare the regulatory strategy for product registration with the support of the Central RA team.
3. Manage all product (Medicines and non – medicines) life cycle, including variations, renewals and
other local requirements.
4. Manage via Corporate systems all the activities needed to ensure full compliance of labelling and
artworks, according to local/European requirements and Company standards.
5. Revision and clearance via corporate systems of advertising materials to ensure full compliance with local/European regulatory requirements, internal data, documentation and processes.
6. Prepare and submit all Pricing applications.
7. Provide Budget estimate for each Fiscal year and keep control of the expenses.
8. Interact with Ministry of Health and other Regulatory Authorities for above activities creating and
fostering a network of contact to facilitate dialogue during regulatory procedure. Represent the MA
Holder (MAH) in all matters relevant to medicinal products and other Personal Health products (e.g.
medical devices, food supplements, cosmetics), including regulatory questions, issues and crisis.
9. Ensure full compliance to national/ European regulations, Company standards and SOPs of all
marketed products.
10. Accurate maintenance of Corporate System and Databases for products information, data and
documentation.
11. Management of any external database required for maintenance of medicinal and non-medicinal
products.
12. Keeping up to date on and interpreting national and international RA legislation and regulations.
13. Represent the company in Industry Associations and Technical Working Groups.
14. Lead key Medical and Professional & Technical Affairs activities across, including but not limited to: ensuring compliance of all Technical Proof of Claim materials against government and industry regulations; provide the local support to develop of technically strong scientific promotional materials aimed at the health-care professional (advertising, detailing sales aid, demos, newsletters, slide decks, etc)
Education: Master/PhD in Life science or Pharmaceuticals
Skills: Minimum 3 years of experience in similar position
Ability to work effectively and build superior relationships with external stakeholders
Strong initiative and follow-through
Excellent communication and presentation skills
Languages: Bilingual French and English is a must. Netherlands will be considered as an asset.
Permanent position within an international company very well established.
The successfull candidate will be granted with a global package (fix, variable and extra legals advantages) in line with his/her experience.
Mathieu Devaux
+32 2 509 45 68
Bastion Tower
Marsveldplein 5
Place du Champ de Mars 5
1050 Brussels
http://bit.ly/2CXh6cN
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