The Opportunity:

The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management. This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success.

In addition to strategic leadership, this role will build and scale fit-for-purpose regulatory processes, frameworks, and capabilities to support portfolio growth. The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.

Primary Responsibilities:

Global Regulatory Strategy

• Develop, own, and execute the global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management.
• Serve as the accountable global regulatory lead for assigned molecule(s), ensuring regulatory strategies support corporate objectives, development milestones, and global registration plans.
• Develop innovative regulatory approaches that enable efficient clinical development and maximize opportunities for expedited pathways.
• Anticipate regulatory risks, evaluate potential impact, and develop proactive mitigation strategies.
• Maintain and oversee the execution of the integrated global regulatory strategy for a product that aligns cross-functional development plans, regulatory requirements, and commercial objectives.
• Monitor the evolving global regulatory environment and provide regulatory intelligence that informs development strategy, competitive positioning, and organizational decision-making.

Health Authority Leadership

• Provide strategic oversight for global Health Authority interactions, including FDA, EMA, PMDA, MHRA, and other international agencies.
• Define the regulatory objectives, messaging, and overall strategy for key Health Authority meetings, including Pre-IND, End-of-Phase, Type B/C, Scientific Advice, and other critical interactions.
• Provide strategic guidance for the preparation of briefing documents, meeting requests, responses to agency questions, and regulatory correspondence.
• Interpret Health Authority feedback and translate it into actionable regulatory and development strategies for cross-functional teams.

Regulatory Submission Leadership

• Provide strategic oversight for the planning and execution of major regulatory submissions, including INDs, CTAs, amendments, expedited designation requests, marketing applications, and lifecycle submissions.
• Ensure submission strategies align with the overall global regulatory strategy, development objectives, and applicable regulatory requirements for the molecule.
• Provide strategic direction for the content and messaging of key regulatory documents to clearly communicate the scientific rationale, development strategy, and benefit-risk profile of assigned programs.
• Partner closely with Regulatory Operations, Medical Writing, Clinical Development, Biometrics, and CMC to deliver high-quality global submissions.

Cross-Functional Leadership

• Represent Regulatory as a core member of cross-functional molecule and development teams.
• Provide strategic regulatory guidance for clinical development plans, protocol design, indication expansion, and lifecycle opportunities.
• Partner closely with Clinical Development, Clinical Operations, Safety, Nonclinical, CMC, Biometrics, Medical Writing, Program Management, and Commercial to ensure regulatory strategy is fully integrated into program execution.
• Communicate regulatory strategy, risks, tradeoffs, and recommendations to senior leadership and governance committees.

Leadership & Collaboration

• Foster a collaborative, solutions-oriented approach across cross-functional teams.
• Manage regulatory leads and support teams and contribute to development of regulatory capabilities across the organization.
• Champion regulatory excellence, continuous improvement, and strategic thinking throughout product development.

Required Skills, Experience and Education:

• Advanced scientific degree (PhD, PharmD, MD, or equivalent); MS with significant relevant experience may be considered.
• Approximately 12+ years of regulatory affairs experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience serving as the Global Regulatory Lead for oncology development programs.
• Significant experience developing global regulatory strategies from early development through registration.
• Proven success leading FDA and global Health Authority interactions.
• Experience leading INDs and major global regulatory submissions.
• Strong knowledge of global regulatory requirements across all phases of drug development.
• Excellent communication, negotiation, and cross-functional leadership skills with the ability to influence without direct authority.

Preferred Skills:

• Experience with targeted oncology therapies and precision medicine.
• Experience supporting accelerated approval pathways, including Fast Track, Breakthrough Therapy, Priority Review, Sakigake, PRIME, or comparable programs.
• Experience supporting global registrations across multiple regions.

#LI-Hybrid #LI-SH1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Base Pay Salary Range

$244,000-$305,000 USD

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