Global Oncology Regulatory Strategy Director

Biopharma Careers; Upper Providence (Delaware County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

GSK is seeking a Director, Global Regulatory Strategy - Oncology to develop and execute regulatory plans for oncology assets, ensuring alignment with development strategies and market requirements. The role includes leadership of regulatory teams and cross-functional collaboration with clinical, safety, and commercial functions.

The position requires extensive experience in regulatory affairs, including interactions with health authorities, and a track record of strategic regulatory

Qualifications

• Bachelor's degree in biology, life sciences, healthcare sciences, pharmaceutical sciences, regulatory science, or related discipline.
• 8+ years of experience in Regulatory Affairs within pharma/biotech/healthcare.
• 6+ years of experience supporting drug development in multiple phases.
• 3+ years developing and executing global regulatory strategies in Oncology.
• Experience leading Health Authority interactions and regulatory milestones.
• Experience cross-functional development teams (Clinical, Safety, Commercial, Statistics, CMC, R&D).
• Experience applying regulatory precedent and intelligence to programs.
• Experience supporting regulatory activities in major global markets (US, EU, others).
• Experience influencing senior stakeholders in a matrix environment.

Responsibilities

• Lead or oversee development and execution of regulatory strategies for assets.
• Provide regulatory leadership including assessment of precedent and competitive landscape.
• Lead or contribute to interactions with health authorities and regulatory review processes.
• Collaborate with Early Development, Medicine Development, local regulatory teams, and partners.
• Accountable for regulatory work packages and participate in Regulatory Matrix Team activities.
• Ensure activities comply with laws, regulations, and internal policies.
• Contribute regulatory input to due diligence and portfolio assessments.
• Mentor and develop team members and support resource planning.
• Partner with senior stakeholders on program strategy and long-term objectives.
• Clearly communicate strategy, risks, and recommendations to senior leaders and cross-functional partners.

Skills

Business resilience

Communication

Digital fluency

Matrix leadership

Pharmaceutical regulatory compliance

Regulatory strategies

Resource management

Stakeholder management

Education

Bachelor's degree in biology/life sciences/related

Advanced degree (MS/PhD/MDS/PharmD) preferred

Job description

GSK is seeking a Director, Global Regulatory Strategy - Oncology to develop and execute regulatory plans for oncology assets, ensuring alignment with development strategies and market requirements. The role includes leadership of regulatory teams and cross-functional collaboration with clinical, safety, and commercial functions.

The position requires extensive experience in regulatory affairs, including interactions with health authorities, and a track record of strategic regulatory