Regulatory Affairs Lead

Job description

Ref. : MEC 242

 

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.

 

Principal Accountabilities:

  • Obtain and maintain regulatory approvals for Galapagos’ products.
  • Regulatory expert for assigned compounds, provide regulatory scientific and strategic guidance for effective and compliant compound development.
  • Implement and execute the regulatory strategy endorsed by the project team.
  • Ensure full compliance with all applicable regulations and ensure this is reflected in the company processes.
  • Act as company representative towards health authorities.

 

Requirements

Education

University degree in health sciences, pharmacy, biological science, chemistry or related field.

Experience

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.

General Skills

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.

Communication Skills

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.