Vice President Regulatory CMC

2 weeks ago

Somerset NJ, United States KayeBassman International Full time

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.

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.

An advanced degree (MS, PhD, PharmD) is strongly preferred. 15+ years of progressive Regulatory CMC experience, including senior leadership roles.
~ Demonstrated success leading global Regulatory CMC strategies and major submissions.
~ Experience in both biotechnology and pharmaceutical environments.
~ Demonstrated ability to supervise Regulatory CMC staff and contract CMC Regulatory

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