You will be responsible for defining and implementing regulatory strategies from preclinics up to registration. You will also be responsible for ensuring compliance with applicable regulations and will contribute to out-licensing activities. Your role is key for defining development paths for Formycon’s development projects. In this position you reports directly to the Director of Regulatory Affairs and Quality Man-agement.
- Define RA strategy for Formycon’s development projects with main focus on US and Europe and lead its implementation
- Ensure timely preparation of regulatory documents (e.g. Briefing Books, IMPD/IND; BLA/MAA)
- Guide cross-functional teams in defining the best strategy for each submission, their content and the contribution of each team member to their preparation
- Lead and coordinate submissions, such as: INDs/CTAs, Briefing Documents for Health Authorities, PIP/PSP, MAA/BLAs etc.
- Coordinate health authority interactions and support to prepare the team for meetings with FDA/EMA and other Regulatory Agencies
- Maintain knowledge of global competitive landscape, regulatory environment, and regulations
- Manage regulatory CROs in charge of assigned work packages
- Contribute to the continuous improvement of internal processes, maximizing opportunities for improvement while ensuring compliance to applicable regulations
- Management responsibility for regulatory affairs team (>10 team members); develop, direct and coach direct reports
- Compilation and maintenance of project, budget and capacity plans
Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.
Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.