Juul van Heek
Regulatory Affairs Associate
Juul graduated with a master’s degree in biomedical science at the university of Groningen in 2016. In the following 3.5 years he worked as a sales representative and then another 2 years as a medical science liaison for the same pharmaceutical company. End of 2022, he joined DADA to support the
Pharmaceutical Safety and Efficacy team.
In his role as an RA Associate, he is involved in both pre‑authorisation and post‑authorisation activities.
For pre‑authorisation, he supports the preparation of clinical and non‑clinical overviews for pharmaceutical dossiers and prepares documentation for Marketing Authorisation Applications (MAA) submitted through national, MRP, and DCP procedures. He also supports the translation of SmPCs, product information, and labelling materials.
For post‑authorisation, he leads the Advertising and Compliance team at DADA and is responsible for additional risk‑minimisation materials. He supports Market Access activities and contributes to the planning and submission of Early Access Programs, Compassionate Use Programs, Named Patient Programs, and requests for waivers for non‑localised packaging. In addition, he assists in the preparation of documentation for variations, renewals, and responses to regulatory authority questions.

