Sr Director, Regulatory Affairs Strategy
About the Role
The Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects throughout development and lifecycle management by providing regulatory thought leadership and leveraging their extensive development experience. The individual will provide strategic as well as tactical regulatory leadership across all phases of product development, filing, and lifecycle management, to assure timely approval and compliant post-market performance in the US and key international markets. The individual should be able to proactively anticipate and mitigate regulatory risk, ensure compliance with global regulatory requirements and develop development acceleration strategies. In-depth understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices is required. The role will require strong leadership and interpersonal skills, both written and verbal. The candidate must have at least 15 years of regulatory affairs experience in the US and ex-US environments and a higher degree (MS, Ph.D. or PharmD) in a scientific discipline.
Key responsibilities of the role:
- Serve as leader internally by collaborating across organizational levels and functions and effectively engaging stakeholders and influencing cross-functional decision-making to drive regulator
