Ref. : MEC 242
This position can also be located in LEIDEN. Some travel will be required.
The Regulatory Affairs Lead is the regulatory scientific expert and a standing member of assigned compound development project teams. In this role, the Regulatory Lead delivers the regulatory strategy and executes this strategy upon endorsement by the project team, in an effective and compliant manner throughout all phases of development.
University degree in health sciences, pharmacy, biological science, chemistry or related field.
A minimum 10 years of relevant experience in medicinal product development in a broad range of regulatory affairs projects in the pharmaceutical/biotech industry and/or with regulatory authorities. A profound and demonstrated knowledge of the international regulatory affairs environment with a sound understanding of the pharmaceutical/biotech business-environment is essential.
Previous experience in an international context or in an alliance or collaborative product development setting with an external partner is desirable.
Demonstrated ability to manage multiple tasks/projects/priorities and complex issues. Strategic thinker, able to provide clear regulatory guidance and steering to multifunctional project teams. Demonstrated attitude of reliability and attention to detail. Team player showing professionalism towards external and internal contacts.
Strong verbal and written communicator in English language, multilingual is an asset. Diplomatic attitude with excellent negotiation skills allowing reaching a consensus between different stakeholders.