Hiring: Director, Global Regulatory Affairs Lead (Oncology) Company: GSK Location: Collegeville, PA Job Posted Time: 2026-09-10 13:52:19 Employment Type: Remote Target Skills & Keywords : R, Regulatory Compliance, Stakeholder Management About the job Experience: •8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry. •6+ years of experience supporting drug development programs spanning multiple phases of clinical development. •3+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology •10+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry. Required Skills: •Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements. •Provide regulatory leadership for assigned programs, including assessment of regulatory precedent, regulatory intelligence, competitive landscape, and potential impact on asset strategy. •Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes, as applicable to assigned programs. •Interface directly with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross-functional stakeholders to support regulatory strategy and labeling objectives that are consistent with available data. •Serve as a point of accountability for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable. •Ensure regulatory activities are conducted in accordance with applicable laws, regulations, internal policies, and GSK expectations. •Provide regulatory input into due diligence, business development, or portfolio-level assessments, as needed. •Where the role includes people leadership, manage and develop direct or indirect team members, support workforce planning, contribute to resource management, and help build effective, inclusive teams. Qualifications: •Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline. Compensation: •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package 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!