Job Description

Director, Regulatory Affairs

W2 Contract-to-Hire

Salary Range: $218,400 - $239,200 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

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, as well as strong leadership and relationship-building ability.

Duties and Responsibilities:

• Deliver a sound regulatory strategy to program teams.
• Motivate, mentor, and develop direct reports.
• Ensure drug development programs are fully resourced for applicable stages of development. Anticipate upcoming work; ensure robust and effective regulatory strategy support.
• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.
• Ensure regulatory advice, policy, and decision-making are consistent across programs and that learnings from one program are fully considered in all other programs.
• 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 and Qualifications:

• 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.
• Demonstrated success in leading regulatory submissions globally
• Direct experience with oncology drug development.
• Experienced in representing Regulatory 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.

Preferred Qualifications:

• An advanced degree is desirable.
• Experience with combination studies, multiple expansion cohorts, basket or umbrella, and master protocols is highly preferred.
• Prior NDA experience is highly preferred.

Desired Skills and Experience

Regulatory Affairs, Regulatory Strategy, Oncology Drug Development, FDA Regulations, Health Authority Interactions, Clinical Research, Clinical Operations, Medical Writing, Quality Assurance, Cross-functional Leadership, Team Management, Mentoring, Regulatory Submissions, Global Regulatory Submissions, NDA Experience, Combination Studies, Expansion Cohorts, Basket Studies, Umbrella Studies, Master Protocols, Drug Development Strategy, Regulatory Policy Development, Pharmaceutical Industry, Biotech Industry, Life Sciences, Strategic Planning, Project Management, Senior Management Presentations, Stakeholder Management, Competitive Intelligence, Regulatory Compliance, Clinical Trial Design, Program Management, Risk Assessment, Regulatory Documentation, IND Submissions, BLA Submissions, Regulatory Intelligence, Health Authority Negotiations, Regulatory Guidelines, ICH Guidelines, Oncology Therapeutics, Drug Development Lifecycle, Regulatory Operations, Change Management, Process Improvement, Team Building, Performance Management, Resource Planning, Strategic Decision Making, Regulatory Affairs Leadership, Pharmaceutical Regulations, Clinical Development, Drug Approval Process

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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