About the job
We are seeking for a Regulatory Affairs Officer/Specialist responsible for ensuring the delivery of regulatory activities performed on the Benelux market.
About us
Group 10 Responsibilities
1. Ensure that the regulatory tasks and functions within the Regulatory Affairs Department are carried out efficiently and effectively
2. Management of new MAA and post approval activities for Benelux market
3. Obtaining and maintaining marketing authorization approval for the client’s pharmaceutical products
4. Providing strategic regulatory input from local market
5. Secure essential interface with authorities
6. Maintaining strong and positive working relationships with the clients
Group 11 Profile and Skills
7. Similar experience of 2+ years is mandatory
8. Local expertise on BENELUX legislation
9. Management of artwork generation, experience of promotional/non-promotional activities would be an advantage
10. Experience of operating in EU context
11. Good IT skills/knowledge
12. Good organizational skills
13. Good communication skills in Dutch and English are mandatory for business continuity.
14. Proactive attitude and able to work on own initiative as well as part of a team
15. Ability to prioritise different workloads/multi-task
16. Personal responsibility for ensuring a high standard of work