Vice President, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and execute worldwide regulatory strategies for cell therapy initiatives throughout clinical development, manufacturing, and commercialization.

• Act as the primary regulatory consultant to executive leadership, ensuring alignment with corporate goals and regulatory standards.

• Anticipate and analyze changing regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP regulations.

• Evaluate and communicate potential regulatory risks and recommend mitigation strategies.

• Collaborate with cross-functional teams, including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs, to create and implement competitive regulatory strategies that accelerate development and enhance the likelihood of success for cell therapy product development.

• Supervise the preparation and submission of INDs, CTAs, BLAs/MAAs, and other pertinent submissions to regulatory authorities.

• Direct strategies for global expedited pathways (e.g., RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (in the US and EU), as applicable.

• Ensure program and submission documentation compliance with GxP, ICH, and regional regulatory standards throughout development and manufacturing.

• Establish and nurture strong relationships with FDA CBER and other regulatory bodies, representing the company in crucial regulatory meetings and negotiations.

• Ensure prompt and high-quality responses to health authority inquiries, including pre-BLA meetings, Type B/C/D meetings, and scientific advice.

• Build and lead a high-performing regulatory affairs, operations, writing, and CMC regulatory team with expertise in cell and gene therapy.

• Promote a culture of compliance, innovation, and continuous enhancement.

• Mentor team members on technical skills and leadership competencies.

⛳️ Requirements

• Advanced degree in life sciences, pharmacy, or a related field (PhD, PharmD, or equivalent preferred).

• Over 15 years of regulatory affairs experience in biopharmaceuticals from pre-clinical phases to commercialization, with a minimum of 8 years in leadership positions.

• Preferred experience in the cell and gene therapy sector.

• Documented success in IND and BLA submissions (prior BLA experience required).

• Extensive knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks.

• Strong leadership, strategic thinking, and negotiation abilities.

• Excellent communication skills and stakeholder management capabilities.

• Strong team orientation and a passion for ongoing self-improvement.

🏝️ Benefits

• Competitive benefits.

• PTO.

• Stock option plans.