Regulatory Affairs Specialist 916
il y a 3 semaines
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We are seeking a Regulatory Affairs Officer/Specialist responsible for ensuring the delivery of regulatory activities performed on the Benelux market.
About UsGroup 10 Responsibilities
About the JobWe are seeking a Regulatory Affairs Officer/Specialist responsible for ensuring the delivery of regulatory activities performed on the Benelux market.
Responsibilities- Ensure that the regulatory tasks and functions within the Regulatory Affairs Department are carried out efficiently and effectively.
- Management of new MAA and post approval activities for the Benelux market.
- Obtaining and maintaining marketing authorization approval for the client's pharmaceutical products.
- Providing strategic regulatory input from the local market.
- Secure essential interface with authorities.
- Maintaining strong and positive working relationships with clients.
- Similar experience of 2+ years is mandatory.
- Local expertise on BENELUX legislation.
- Management of artwork generation; experience in promotional/non-promotional activities would be an advantage.
- Experience of operating in the EU context.
- Good IT skills/knowledge.
- Good organizational skills.
- Good communication skills in Dutch and English are mandatory for business continuity.
- Proactive attitude and ability to work on own initiative as well as part of a team.
- Ability to prioritize different workloads/multi-task.
- Personal responsibility for ensuring a high standard of work.
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