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Director of Regulatory Affairs
700 Saginaw Drive Redwood City, CA 64063 US
Job Description
The Opportunity: Director of Regulatory Affairs
The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.
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Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
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Motivate, mentor and develop direct reports to ensure development and performance.
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Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.
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Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.
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Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.
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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.
Required Skills, Experience and Education:
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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.
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Proven success in developing and delivering global regulatory strategies and submissions.
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Demonstrated success in leading health authority interactions and negotiations.
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Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.
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Strong track record in alliance management, coordinating with external development or commercialization partners.
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Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
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Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
Preferred Skills:
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An advanced degree is desirable.
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Experience with dose optimization in oncology.
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Prior NDA experience is highly preferred.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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