The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Director of Regulatory Affairs will join a late stage biopharmaceutical company located in San Diego and focused on developing new therapies for cancer. He/She will contribute to the development and execution of successful regulatory strategy to support investigational products for new or active US and global oncologyclinical studies. Candidate will also represent the RA group as part of cross-functional teams to provide regulatory support and guidance and will be the Regulatory lead for Phase 3 global studies and work with a strong group of leaders.
At least 8 years’ experience with small molecules in Regulatory Affairs within a pharma, biopharma or biotechnology company
Experience in Phases 1-3 and commercial product lifecycle
Accomplished in preparation and submissions of INDs, IMPDs, NDAs
Demonstrated experience interacting with FDA and EMA
Additional Salary Information: Competitive
Internal Number: 021621
About Bente Hansen & Associates
Bente Hansen & Associates is a boutique, retained executive search firm focused on the life sciences and healthcare industries. The firm was founded in 1999 by Bente Hansen following her leadership roles in two national search firms, DHR International in Chicago and Gilbert Tweed in New York where she led the life science portfolios. The Company is independent and smaller by design and measures success by the quality of the candidates presented, responsiveness to the search, ability to match cultural fit and ultimately, the contributions of the hired individual. The Company has grown through repeat business and referrals.