Senior Director, Regulatory Affairs
Massachusetts - United States
Seeking an experienced Senior Director of Regulatory Affairs to contribute to the development and implementation of regulatory strategy for specific projects for the treatment of cancer and other major diseases. Seeking an experienced regulatory leader to represent the department in project teams. This Senior Director will serve as the Regulatory Lead on projects to execute submissions and will be the regulatory point-of-contact with relevant regulatory authorities. Seeking a Regulatory Affairs professional with strong leadership skills and interpersonal skills who has a successful track record of developing and executing regulatory strategy while working collaboratively cross-functionally with the team and a variety of personnel and staff.
- Direct interactions with appropriate regulatory authorities; participate, support and contribute to health authority meetings.
- Provide regulatory expertise and support clinical and non-clinical areas for investigational products; ensure these programs are thoroughly planned and executed to meet all regulatory requirements and guidelines.
- Ensure regulatory compliance with pre and post-approval filings; reporting requirements as expected.
- Contribute to the development and execution of clinical and pre-clinical regulatory strategies for projects in all stages of development (i.e.: pre-IND/IMPD through commercial).
- Develop response strategies and submissions to appropriate regulators, and address and resolve regulatory issues as they arise.
- Provide regulatory leadership and guidance to project teams and lead the development and strategy of global regulatory submission documents.
- Provide development and mentorship to the junior regulatory staff.
- Develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities.
- Identify and assess regulatory risks for assigned projects or programs.
- Prepare and deliver effective presentations for external and internal audiences.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Address and resolve regulatory issues arising in pre-clinical, clinical and commercial development programs.
- Experience in the interpretation of regulations, guidelines, policy statements, etc.
- Strong knowledge of global regulatory requirements is required.
- Prepare NDAs/MAAs and experienced within a matrix environment.
- Knowledge and experience in the preparation of major regulatory submissions and has prior experience supporting amendments or supplements.
- Master's degree in life sciences/health/technical sciences is required.
- 10+ years of regulatory experience or an Advanced degree (phD/PharmD or equivalent) with a minimum of 5 years of experience within the biotech/pharmaceutical industry.
- 7 years of regulatory experience within the drug development and approval process in IND/CTA/Marketing Applications.
- Key skills: Leadership, management, communication, negotiation and presentation skills.
If interested in learning more, please contact me at firstname.lastname@example.org or (646) 430-1191 for more information.