Vice President Regulatory CMC

Job Description

Retained Search

Hybrid Position

Our client is a global, clinical-stage biopharmaceutical organization developing innovative therapies for serious immunologic diseases with significant unmet medical needs. The company is seeking a Vice President, Regulatory CMC to provide strategic leadership across global regulatory CMC activities. This is a high-impact opportunity to lead strategy across development and commercialization while partnering closely with senior leadership and cross-functional teams.

Position: The Vice President, Global Regulatory CMC, will be responsible for developing and executing global regulatory strategies to support a biologics and combination product pipeline. This leader will oversee global regulatory submissions and interactions with health authorities while building and scaling a high-performing regulatory organization.

KEY RESPONSIBILITIES:

• Lead and execute global regulatory CMC strategy across development and lifecycle management.
• Serve as the primary regulatory CMC interface with FDA, EMA, and global health authorities.
• Provide executive oversight and hands-on leadership for INDs, BLAs, NDAs, MAAs, CTAs, and regulatory CMC briefing packages.
• Guide regulatory CMC strategy for biologics and drug-device combination products.
• Partner cross-functionally with Clinical, Regulatory, Quality, Manufacturing, and Commercial teams.
• Anticipate regulatory risk and provide proactive mitigation strategies.
• Ensure regulatory plans align with corporate objectives and timelines.
• Build, mentor, and scale the global Regulatory CMC organization.
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities.

QUALIFICATIONS:

• An advanced degree (MS, PhD, PharmD) is strongly preferred. US RAC certification is a plus.
• 15+ years of progressive Regulatory CMC experience, including senior leadership roles.
• Demonstrated success leading global Regulatory CMC strategies and major submissions.
• Extensive experience interfacing directly with global health authorities
• Experience supporting early- and late-stage development programs
• Extensive experience in biologics and combination products required.
• Proven ability to lead, mentor, and develop teams.
• Strong executive presence, strategic thinking, and communication skills.
• Experience in both biotechnology and pharmaceutical environments.
• Demonstrated ability to supervise Regulatory CMC staff and contract CMC Regulatory