Job description
About the jobWe are seeking for a Regulatory Affairs 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 Benelux market
Obtaining and maintaining marketing authorization approval for the client’s pharmaceutical products
Providing strategic regulatory input from local market
Secure essential interface with authorities
Maintaining strong and positive working relationships with the clients
Profile and Skills
Similar experience of 3/4 years is mandatory
Local expertise on BENELUX legislation
Management of artwork generation, experience of promotional/non-promotional activities would be an advantage
Experience of operating in EU context
Good IT skills/knowledge
Good organizational skills
Good communication skills in Dutch and English are mandatory for business continuity.
Proactive attitude and able to work on own initiative as well as part of a team
Ability to prioritise different workloads/multi-task
Personal responsibility for ensuring a high standard of work
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