Director, Regulatory Affairs
About The Position
The Opportunity: Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs. Anticipate regulatory needs to deliver on program milestones. Develop robust global regulatory strategies that reflect global marketing application filing strategies, expert input, and align with corporate goals to ensure global success. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.
Requirements
- Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
- Proven success in developing and delivering global regulatory strategies and submissions, working independently.
- Previous experience with NDA and/or global marketing application filings.
- Previous experience with global ODD annual reports.
- Demonstrated success in leading health authority interactions and negotiations.
- Direct experience in oncology drug development including oversight of large, global Phase 3 studies.
- Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
- Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
Nice To Haves
- An advanced degree is desirable.
- Experience with dose optimization in oncology.
- Prior NDA experience.
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What This Job Offers
Job Type
Full-time
Career Level
Director
