- 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.
- Obtain and maintain regulatory approvals for company’s 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.
- 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 multi-functional 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.