Senior Director, Regulatory Affairs

AVENZO THERAPEUTICS INC • San Diego, CA

20h • Hybrid

About The Position

Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization. This individual will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements.

Requirements

• Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 12+ years of regulatory affairs experience in the life sciences industry or an equivalent combination of academic and industry experience
• Direct experience supporting early-stage (pre-IND to Phase 1/2) solid tumor oncology programs
• Familiarity with multiple oncology modalities (e.g., small molecules, biologics, ADCs)
• Demonstrated ability to develop, lead, and implement global regulatory strategies for complex development programs across multiple phases of the product lifecycle
• Extensive knowledge of U.S. and international regulatory requirements, including FDA and EMA regulations, guidance, and industry standards applicable to oncology development programs
• Proven experience leading major regulatory submissions and global filing activities (e.g., INDs, CTAs, and, as applicable, BLAs, MAAs, NDAs/NDSs)
• Demonstrated success leading regulatory interactions with health authorities, including briefing package development, response strategy, and negotiation of regulatory positions and commitments
• Strong track record of independent decision‑making, regulatory risk identification, and development of mitigation strategies affecting program and portfolio outcomes
• Demonstrated ability to influence and lead cross‑functional teams in a matrix environment, providing strategic regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, and related functions
• Strategic thinker with strong analytical judgment, problem‑solving skills, and the ability to thrive in a fast‑paced, evolving biotech environment
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset
• This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel

Nice To Haves

• advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.)

Responsibilities

• Develop and execute U.S. and global regulatory strategies for one or more solid tumor oncology programs across the clinical development lifecycle, aligned with corporate and program objectives
• Serve as the Regulatory Affairs lead on cross‑functional program teams, providing regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, Quality, and other stakeholders
• Lead the strategic planning, review, and execution of regulatory submissions and maintenance activities (e.g., INDs, CTAs, amendments, briefing packages, and, as applicable, BLAs/MAAs), ensuring compliance with global regulatory requirements
• Assess and pursue oncology-specific expedited programs and designations, including Fast Track, Breakthrough Therapy Designation, Orphan Drug Designation, Accelerated Approval, and EMA PRIME, as appropriate for solid tumor indications
• Lead and coordinate health authority interactions, including meeting strategy, preparation and oversight of briefing documents, responses to requests for information, and management of post‑meeting commitments
• Conduct regulatory risk assessments and gap analyses; identify potential issues and develop mitigation strategies to support successful regulatory outcomes
• Provide regulatory leadership in the assessment of emerging clinical data and operational activities, evaluating regulatory impact and advising on strategy adjustments as needed
• Contribute to and/or lead the development and review of key regulatory documents, including, clinical protocols, and clinical and nonclinical study reports
• Drive high‑quality execution of regulatory deliverables, including alignment of timelines, content consistency across documents, and adherence to internal standards and best practices
• Translate evolving global regulatory guidance and regulatory intelligence into actionable recommendations for program teams and senior leadership
• Support the growth and scalability of the Regulatory Affairs function through process improvement, cross‑functional alignment, and mentoring of internal team members and external partners, as appropriate
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset
• This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel

Benefits

• medical, dental, vision, and basic life and AD&D insurance
• short-term and long-term disability insurance
• flexible spending accounts
• health savings accounts
• voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
• 401(k) plan
• 10 hours of paid vacation time every month
• 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays each calendar year, including a winter closure

What This Job Offers

• Job Type: Full-time
• Career Level: Senior