A growing clinical-stage biotech is looking for an experienced Head of RA to assume global-level responsibility of the company as they expand and register new products.
In the Regulatory Department, reporting to the Chief Medical Officer, you will be a core team member within a matrix organization. You will be actively involved in organizing and executing the regulatory strategy and managing the regulatory department.
Key responsibilities of the Global RA Head include:
- Leads the development and execution of the long-term global regulatory strategy for the product portfolio
- Provides relevant input and ensures preparation of the Strategic Portfolio Committee (SPC) review with the Executive Committee (ComEx)
- Actively collaborates (for products placed on the market) with medical affairs. In all cases, collaborates with safety, who is in charge of the evaluation of the side effects and risks linked to the use of the product, as well as in phase marketing
- Gives overall guidance for regulatory regulations
- Manages and leads the global regulatory team on work missions and objectives
- Provides leadership and participates in skill-development, performance feedback, coaching and mentoring, fostering an environment and culture of learning and sharing best practices
- Oversees CROs and other external partners
Key requirements of the Global RA Head include:
- Advanced degree in scientific discipline (Ph.D., PharmD or MD degree preferred) and/or other appropriate knowledge/experience
- 10 yrs + of pharmaceutical/ biotechnology industry experience (in biologics)
- Established knowledge in oncology, hematology, and immunology
- Experience in the regulatory design and conduct of clinical trials for a period of at least 10 years; experience in all phases of clinical development (phase I to IV) and worldwide experience of regulatory submissions and approvals
- Proven track record of development success in developing and getting products to the market (e.g., NDA/BLA/MAA submissions and approvals)
- Track record of post-marketing activities experience
- Strong knowledge of FDA and EMEA regulations and guidelines
- Excellent command of the English language, other languages beneficial
