Director, Regulatory Affairs CMC

Vertex Pharmaceuticals - Boston, MA

Hiring: Director, Regulatory Affairs CMC Company: Vertex Pharmaceuticals Location: Boston, MA Job Posted Time: 2026-09-10 11:47:34 Employment Type: Hybrid About the job Experience: •10+ years of pharmaceutical, biotechnology, or related industry experience supporting small molecule development. •3+ years of people management experience leading technical and/or regulatory professionals. •Demonstrated leadership in global matrix organizations. •May have budgetary and direct people-management accountability. •Commitment to innovation, continuous improvement, and operational excellence. Required Skills: •Leads development and execution of global CMC regulatory strategies for multiple investigational and marketed products in the small molecule portfolio. •Oversees preparation, review, and approval of CMC content for global regulatory submissions. •Provides strategic leadership for Health Authority interactions and negotiations. •Leads and develops Regulatory CMC staff through coaching and talent development. •Ensures consistent regulatory guidance to cross-functional stakeholders. •Serves as senior Regulatory CMC representative on governance bodies and product teams. •Identifies regulatory risks and develops mitigation strategies. •Drives continuous improvement through structured content and digital regulatory capabilities. Qualifications: •Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences discipline. Advanced degree (M.S., Pharm.D., or Ph.D.) preferred. Compensation: •$190,400 - $285,600 / year •Flexible work environment (work from home / hybrid options) •This role is eligible for an annual bonus and annual equity awards Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!