Senior Director, Regulatory Affairs

Location:

Redwood City, CA - Hybrid Role

Job Summary:

We are seeking an experienced Senior Director, Regulatory Affairs to lead global regulatory strategy for one or more clinical-stage programs, with a primary emphasis on FDA-facing activities. Reporting to the VP/SVP, Regulatory Affairs or designee, this leader will own the regulatory strategy for assigned programs from IND/CTA through late-stage development and preparation for marketing applications. The role serves as the primary interface with the FDA and coordinates with international health authorities, partnering closely with Clinical Development, Clinical Operations, CMC, Nonclinical, and Quality to advance the pipeline. This is a high-visibility role for a strategic, hands-on regulatory leader who thrives in a fast-moving, science-driven environment.

Duties and Responsibilities:

• Develop, communicate, and execute global regulatory strategies for assigned clinical-stage programs, aligned with corporate and development objectives.
• Provide strategic regulatory input into integrated development plans, protocol design, endpoint selection, and evidence-generation strategy.
• Identify and evaluate opportunities for expedited pathways (e.g., Fast Track, Breakthrough Therapy, RMAT, Priority Review, Orphan Drug designation) and lead the associated applications.
• Anticipate and assess the impact of evolving FDA, EMA, and ICH regulations and guidance on development programs; advise senior leadership on regulatory risks and mitigation strategies.
• Serve as the primary point of contact with the FDA for assigned programs; lead the planning, preparation, and conduct of agency meetings (pre-IND, End-of-Phase 2, Type B/C, pre-NDA/BLA).
• Lead preparation of briefing documents and coordinate cross-functional teams in developing responses to health authority questions and information requests.
• Coordinate interactions with ex-US health authorities (e.g., EMA, MHRA, Health Canada) directly or through regional partners and consultants.
• Direct the planning, authoring, oversight, and submission of INDs, CTAs, amendments, annual reports/DSURs, and designation requests; drive readiness for NDA/BLA/MAA submissions.
• Establish and manage submission timelines and deliverables with internal teams, CROs, and regulatory publishing vendors.
• Ensure regulatory compliance of trial-related documents and activities, including investigator brochures, safety reporting, and clinical trial registration/disclosure requirements.
• Represent Regulatory Affairs on program teams and governance forums; present regulatory strategy, risks, and options to executive leadership.
• Build, mentor, and develop regulatory affairs staff; manage consultants and vendor relationships to scale capabilities as the pipeline grows.
• Contribute to departmental infrastructure, including SOPs, regulatory intelligence, and inspection-readiness practices.
• Support business development activities with regulatory due diligence and assessments as needed.

Requirements and Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree (PharmD, PhD, MS) preferred.
• 12+ years of biopharmaceutical industry experience, including 8+ years in Regulatory Affairs with progressive leadership responsibility.
• Demonstrated success leading FDA interactions and negotiating development requirements; direct experience preparing for and conducting formal agency meetings.
• Deep working knowledge of FDA regulations and guidance, ICH guidelines, and drug/biologic development across IND through NDA/BLA stages.
• Experience developing global regulatory strategies and coordinating with ex-US health authorities.
• Proven ability to lead cross-functional teams, influence without authority, and communicate complex regulatory issues clearly to executive audiences.

Preferred Qualifications:

• Experience in a clinical-stage or emerging biotech environment, including building processes and capabilities.
• Experience with expedited regulatory pathways and orphan/rare disease designations.
• Direct contribution to a successful NDA, BLA, or MAA submission.
• Regulatory Affairs Certification (RAC) is a plus.

Desired Skills and Experience

Global Regulatory Strategy, Regulatory Affairs Leadership, Clinical-Stage Drug Development, FDA Interactions, Global Health Authority Interactions, INDs, CTAs, NDA/BLA/MAA Readiness, Regulatory Submissions, Agency Meeting Leadership, Briefing Documents, Health Authority Responses, Expedited Regulatory Pathways, Fast Track Designation, Breakthrough Therapy Designation, RMAT Designation, Priority Review, Orphan Drug Designation, FDA Regulations, EMA Regulations, ICH Guidelines, Regulatory Intelligence, Integrated Development Plans, Protocol Design, Endpoint Selection, Evidence Generation Strategy, Regulatory Risk Assessment and Mitigation, Submission Planning and Timelines, Annual Reports, DSURs, Investigator Brochures, Safety Reporting, Clinical Trial Registration and Disclosure, Regulatory Compliance, Inspection Readiness, SOP Development, Cross-Functional Leadership, Executive Communication, Staff Development and Mentoring, CRO and Vendor Management, Consultant Management, Regulatory Due Diligence, Drug and Biologic Development, Regulatory Affairs Certification

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