Regulatory Affairs Senior Vice President

This clinical-stage biotechnology company is changing the treatment of cancer with their novel therapeutic platform. They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory activities and be their primary strategic advisor on global regulatory strategy. You will proactively shape development strategy, lead health authority engagements, and oversee a small Regulatory team. This company offers innovative science, a collaborative and fun company culture, and flexible work arrangements.

With multiple programs in Phase 1 trials, now an exciting time to join this growing organization!

Responsibilities:

• Own and lead global regulatory strategy for the company’s oncology portfolio, including health authority engagement strategy, expedited pathway opportunities, and lifecycle planning.
• Serve as the primary regulatory strategy advisor for the regulatory function; proactively influence program strategy and key development decisions by bringing forward options, tradeoffs, risks, and recommendations.
• Drive a proactive regulatory operating rhythm across programs (decision calendar, scenario planning, and risk mitigation) with a “no surprises” approach.
• Provide key updates and guidance on regulatory strategy, risks, and deliverables to the Executive Team and Board of Directors, as needed.
• Serve as primary contact with FDA and other regulatory agencies, leading communications and meetings, and representing the company with executive-level presence.
• Direct and negotiate submissions (IND, CTA, NDA, BLA, MAA, etc.) with regulatory authorities.
• Strategize, lead, write, and/or supervise the development and submission of documents/dossiers to achieve development goals; ensure on-time, high-quality, regulatory-compliant submissions.
• Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the company.
• Provide strategic direction to all Regulatory functions including hiring, mentoring, and leading staff; build scalable infrastructure and a high-performing team.
• Build key infrastructure (processes, best practices, SOPs) to support development, potential approvals, and commercialization readiness.
• Forecast budgets and develop department best practices and SOPs.
• Provide regulatory leadership and support to project/program teams and senior management for all aspects of the development program.
• Contribute to overall product development strategy and manage development, monitoring, and delivery of regulatory project plans throughout the lifecycle.
• Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the U.S. and globally.

Qualifications:

• Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD Pharm
  
  D, or PhD) preferred.
• A minimum of 20 years of Regulatory Affairs experience in the biopharmaceutical industry.
• Must have extensive Regulatory experience with oncology programs (5 or more years in oncology).
• Experience with biologics programs is preferred.
• A track record of successful interaction with FDA and other regulatory agencies.
• Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
• Ability to review, understand and explain the regulations and guidance documents to guide project teams.
• Experience filing successful marketing applications (NDA, BLA or MAA). Prior successful drug approvals a plus.
• Experience with Orphan Drug Designations, Fast Track, Accelerated Approval, Breakthrough Therapy, and/or Priority Review protocols.
• In-depth understanding of the drug development, product commercialization and life cycle management processes.
• Ex-US or global regulatory experience required.
• Must be an executive-level communicator with strong written/oral skills; able to translate complexity into decision-ready recommendations.
• Strong cross-functional leader who can influence effectively internally and externally and drive alignment in a matrixed organization.
• Comfortable wearing many hats in a small biotech environment while setting a high bar for rigor, accountability, and quality.
• Ability to drive meetings with senior…