Vice President, Regulatory Strategy and CMC

For our client, we are seeking a Vice President, Regulatory Strategy and CMC to join the team of a leader in the Healthcare space. This senior leadership role will shape global regulatory strategy and CMC direction across a portfolio of development programs. The position partners closely with executive leadership, development teams, and external health authorities to guide pathways from early development through commercialization. It will also play a critical role in evaluating regulatory risk, informing portfolio decisions, and ensuring disciplined execution across drug substance, product, and analytical development. Location: Bedford, MA - US based candidates only, no visa sponsorship available Compensation: $345,000 – $395,000 annually Responsibilities Provide oversight for global regulatory strategies across the company’s programs Lead teams managing INDs, CTAs, IMPDs, BLAs, NDAs, MAAs, and post-approval submissions Serve as the executive lead for interactions with global regulatory agencies Offer strategic regulatory guidance to leadership on development pathways and risk mitigation Monitor regulatory requirements and assess impacts on programs Support business development and portfolio evaluation activities Oversee CMC strategies for drug substance, product, and analytical development Qualifications Ph.D., Pharm.D., M.S., or advanced scientific degree in a relevant field preferred 12+ years of experience in biotechnology or pharmaceutical industries, including 6+ years in leadership roles Deep expertise in global Regulatory Affairs and CMC development Proven success in leading major regulatory submissions and health authority interactions Experience advancing products from early development to commercialization Significant experience managing multiple development programs Demonstrated executive leadership in building multidisciplinary teams Benefits Comprehensive medical, dental, and vision insurance Life, long-term, and short-term disability insurance Paid parental leave and unlimited vacation time 401K plan with company match and tuition assistance Participation in an Employee Stock Purchase Program Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.