Regulatory Cmc Jobs

Experienced project manager to lead CDMO management and tech transfer activities for Vertex’s Cell & Gene Therapy program on a 12-month hybrid contract.

Lead analytical science and commercial strategy for biologics and advanced therapies in North America as SGS's Head of Pharma Science.

Experienced CMC leader sought to drive global product development strategy, lead cross-functional teams, and ensure regulatory-ready CMC deliverables for AbbVie's development portfolio.

Lead CMC dossier planning and coordination at AbbVie’s North Chicago site to drive timely, high-quality regulatory submissions and cross-functional alignment.

Lead CMC dossier planning and coordination at AbbVie to ensure timely, high-quality regulatory submission deliverables across late-stage development projects.

Lead and build clinical and commercial supply chain strategy and operations at ORIC to ensure compliant, cost-effective delivery of investigational and commercial drug product across global trials and launch readiness.

Experienced CMC regulatory professional needed to lead global regulatory strategies and submissions for small-molecule drug development at AbbVie’s North Chicago hybrid site.

Lead technical evaluations, due diligence and deal execution for licensing and acquisition opportunities within AbbVie's PDS&T organization to support strategic growth.

Senior regulatory leader needed to lead global regulatory strategy and submissions for DiaMedica’s biologics pipeline, interfacing with FDA and other global agencies.

Technical Writer needed to author and manage CMC regulatory submission content (eCTD/CTD) for a cell therapy portfolio in a hybrid, cross-functional PMO role supporting a biopharma client.

AbbVie is hiring an Associate Director of Program Management to lead global device and combination-product industrialization programs, coordinating cross-functional teams to deliver manufacturing transfers and launches.

Lead Orchard’s US regulatory science strategy as Executive Director, advising cross-functional teams and managing FDA interactions to advance the company’s pipeline.

Senior R&D/Commercial leader to own and drive integrated global asset and brand strategy for aesthetics programs, guiding cross-functional teams from development through commercialization.

Experienced leader needed to own and drive integrated asset and brand strategy for aesthetics R&D programs, ensuring cross-functional alignment from discovery through commercialization.

Gilead seeks an experienced Sr Director to lead CMC Regulatory Affairs digital transformation, driving strategy, vendor programs, and implementation of AI/ML and structured-content solutions to accelerate submissions and improve regulatory outcomes.