You will be leading a small team of Global Regulatory Team Leads (GRTLs) within the MS/Neurology and Immunology & Inflammation (I&I) Global Regulatory Affairs (GRA) team.
- Development and review of regulatory strategies and regulatory “deep-dives”
- Review of regulatory submissions and brief senior members on the review committee on regulatory strategy
- Oversee preparation of regulatory presentations for internal governance meetings
- As a membear of the GRA global management team, be a driver and contributor to regulatory initiatives to improve strategic capabilities and operational excellence
- Exemplify the core values and guiding principles of GRA
- Coach and mentor GRTLs in their roles on global project teams and as leader of the global regulatory team
- Establish a network of internal stakeholders and develop a close working relationship to ensure that GRA is recognized as a valued strategic partner in the development and commercialization of products
- As needed, function as GRTL being the direct responsible for one of the products under responsibility
- Degree in Life Sciences
- Advanced degree is preferred (MS/PhD/PharmD)
- 10-15 years industry experience, with at least 10 years working in regulatory affairs (regionally or globally)
- Management experience of a small team is preferred
- Delivery of a number of major applications (NDA/BLA/MAA/JNDA etc.)
- Experience with late stage development projects is preferred and experience with marketed products is required
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
- Prior experience in Immunology is preferred
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An individual and well-structured introduction and training when you onboard.
- Your professional and personal development will be supported purposefully.
- As a globally successful and constantly growing company, we provide international career paths as well.
For more information please contact me at: +31 (0)20 20 44 502 or firstname.lastname@example.org.