Job Description

Senior Director Regulatory Affairs Strategy

My client is seeking a highly experienced and strategic Director or Senior Director of Regulatory Affairs to lead global regulatory strategies supporting product development and commercialization across key international markets, including the U.S., EU, Japan, Australia, and Canada.

This individual will lead the Global Regulatory Team (GRT) and serve as the primary regulatory liaison to cross-functional development teams and senior leadership. The ideal candidate is proactive, solutions-oriented, and skilled at anticipating and mitigating regulatory risks while ensuring full compliance with global regulatory requirements.

This position requires a deep understanding of drug development, international regulatory frameworks, and accelerated submission strategies. The successful candidate will demonstrate strong leadership behaviors, fostering collaboration and accountability across functions.

This role is offered under a hybrid model based in Palo Alto, California.

Key Responsibilities

• Lead the Global Regulatory Team (GRT) in developing innovative and globally aligned regulatory strategies to achieve company goals for both investigational and marketed products.
• Partner with cross-functional stakeholders to ensure regulatory strategies are accurately reflected in all global submission documents and responses to Health Authorities.
• Serve as the primary regulatory leader and advisor, accountable for ensuring regulatory strategy aligns with corporate and product objectives.
• Develop and maintain regulatory risk assessments and mitigation plans, communicating updates to relevant stakeholders.
• Act as a key internal leader, driving regulatory policy, compliance, and strategy for assigned programs.
• Collaborate closely with the Head of Global Regulatory Affairs (GRA); may lead or participate in company-wide regulatory and strategic initiatives.
• Monitor, interpret, and influence the development of global regulations and guidance, providing strategic analyses and updates to internal teams.
• Exercise sound judgment in making strategic and operational decisions that support program success and corporate goals.
• Represent regulatory affairs in internal governance meetings and external interactions with Health Authorities when appropriate.

Qualifications

• Advanced scientific degree (PhD, MD, or PharmD preferred) or Masters degree in a life science discipline.
• 10+ years of experience in pharmaceutical regulatory affairs, including significant leadership in global regulatory strategy.
• Proven experience as a Global Regulatory Lead (GRL) oncology experience is highly desirable.
• Demonstrated success leading regulatory submissions in multiple major regions, including at least two outside the U.S. (e.g., EU, Japan).
• Strong foundation in global drug development with excellent business acumen and strategic insight.
• Ability to work autonomously and collaboratively in a matrixed, fast-paced environment.
• Excellent written and verbal communication skills, with the ability to influence at all levels of the organization.
• Willingness to travel up to 10% as needed.

We are an equal opportunities employer and welcome applications from all candidates.

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