Dir, Regulatory Strategy

Job description

We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy. This role reports to the Sr Director, Regulatory Affairs (Strategy) Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams Develop and implement global regulatory strategies for pipeline drug development programs and marketed products Identify innovative, data-driven regulatory approaches, define plans to proactively mitigate risks, and monitor the competitive and policy landscape for changes with potential impact Lead the organization and pr...