Director, Global Oncology Regulatory Strategy

GSK plc; Oaks (PA); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Job summary

GSK seeks a Director, Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for assets across development and lifecycle, aligning with development plans and internal policies. You will lead regulatory work packages and collaborate with Early Development Teams and cross-functional partners. This U.S.

hybrid role requires on-site leadership presence for key meetings. Base salary ranges from $171,750 to $286,250 USD annually, with bonus and long-term incentives;

Qualifications

• Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
• 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.
• Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings.
• Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
• Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
• Experience influencing senior stakeholders and providing strategic regulatory recommendations in a matrix environment.
• Demonstrated experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle.

Responsibilities

• Lead or oversee 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.
• Work 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.

Skills

Regulatory leadership

Regulatory strategy

Stakeholder management

Cross-functional teamwork

Education

Bachelor's degree in biology

Advanced degree in science

Job description

GSK seeks a Director, Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for assets across development and lifecycle, aligning with development plans and internal policies. You will lead regulatory work packages and collaborate with Early Development Teams and cross-functional partners. This U.S.

hybrid role requires on-site leadership presence for key meetings. Base salary ranges from $171,750 to $286,250 USD annually, with bonus and long-term incentives;