Description:
The Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. They will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.
- Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies for assigned programs. Translate strategy into specific activities supporting product development and corporate goals.
- Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
- Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure alignment and team effectiveness.
- Responsible for maintaining and applying a working knowledge of the dynamic regulatory landscape in oncology and translating this into actionable steps.
- Manage direct report(s) and provide mentorship to junior professionals.
Required Experience, Skills, and Education:
- Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree is desirable with a minimum of 10 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 6 years in Regulatory Affairs.
- Direct experience with immuno-oncology drug development and checkpoint inhibitors highly preferred. Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred
- Direct experience with FDA expedited programs highly preferred.
- Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.
- Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.
- Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator.
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.