This position will serve as a senior Regulatory Affairs leader and is responsible to shape, manage and lead the Regulatory Affairs function. Primary areas of responsibility will include, but are not limited to:
- Lead and mentor the Regulatory Affairs staff
- Build and expand regulatory capabilities
- Provide subject matter support in Business Development efforts to grow business in Regulatory Affairs
- Serve as primary point of escalation for regulatory related issues/consultation
Manage workload and performance of direct reports, as well as provide them with direction, mentoring, and development opportunities to ensure continued growth within the department.
Provide oversight to Regulatory Affairs staff working to support regulatory activities for different regions around the world, including CMC, nonclinical, clinical and labeling activities.
Contribute to regulatory strategies for clients’ programs which span multiple therapeutic areas and all phases of development, providing support with submission and approval processes for investigational and marketed product applications.
Serve as US Authorized Agent and regulatory liaison with the FDA, and other external contacts. Author regulatory documentation and participate in Agency meetings.
Author regulatory responses to Requests for Proposal, and represent Regulatory Affairs at client meetings, bid defenses, and strategic workshops.
- Significant pharmaceutical industry experience; plus extensive Global Regulatory Affairs experience
- Global / International involvement
- Development, Marketed and Post-Marketed product experience
- Bachelor’s degree in science or health related field required.
- Knowledge of current and emerging issues and trends of the global pharmaceutical regulatory environment. Familiarity with common challenges associated with CMC, non-clinical studies, and clinical trials in pharmaceutical research and development programs.
- Ability to distill highly complex global regulatory requirements and information , and communicate effectively to internal stakeholders and clients
- Development, Commercialization, and Operations