Director Global Regulatory Strategy, Oncology

GSK; United States; Ibrido; USD 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

GSK is seeking a Director, Global Regulatory Strategy- Oncology in the United States. You will develop and execute regulatory strategies for oncology assets, ensuring alignment with development plans, market needs, and regulatory requirements.

You will lead interactions with health authorities and coordinate cross-functional teams globally to drive strategy and approvals. The role may involve people leadership and Global Regulatory Lead responsibilities for multiple assets, with a hybrid work

Competenze

• Bachelor's degree in biology or related field.
• 8+ years in Regulatory Affairs in pharma/biotech/healthcare.
• 6+ years supporting multi-phase drug development.
• 3+ years building global regulatory strategies in Oncology.
• Experience leading Health Authority interactions.
• Cross-functional development team experience (Clinical, Safety, Commercial, Stats, CMC).
• Experience in major markets including US/EU and other jurisdictions.
• Ability to influence senior stakeholders in a matrix environment.

Mansioni

• Lead or oversee development and execution of regulatory strategies for assets; align with development plans.
• Provide regulatory leadership on precedent, intelligence, and landscape impacts on asset strategy.
• Lead/coordinate interactions with health authorities and regulatory review processes.
• Collaborate with Early Development, Medicine Development, local regulatory, commercial partners, and other stakeholders.
• Act as accountable for regulatory work packages and participate in Regulatory Matrix Team activities.
• Ensure activities comply with laws, policies, and GSK expectations.
• Contribute to due diligence, business development, or portfolio assessments as needed.
• Manage and develop teams where leadership is part of the role; workforce planning and resource management.

Conoscenze

Regulatory strategy

Leadership

Cross-functional teams

Regulatory intelligence

Global regulatory

Formazione

Bachelor's degree in Life Sciences

Descrizione del lavoro

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more: Our approach to R&D

Position Summary

The Director, Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory strategies for assigned assets in alignment with medicine development and integrated evidence strategies. This role helps ensure development programs support priority market needs, target medicine profiles, applicable regulatory requirements, and internal GSK policies and processes. The role may include direct or indirect people leadership and may also include Global Regulatory Lead responsibilities for one or more assigned assets.

Key Responsibilities

• 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.
• 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.
• 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.
• Partner with senior stakeholders to support program-level strategy, resource planning, operating model development, and delivery of longer-term objectives or large-scale initiatives.
• Communicate regulatory strategy, risks, options, and recommendations clearly to senior leaders, health authorities, and cross-functional partners.

Why You?

Work arrangement: Hybrid, with regular presence at a US site for leadership activities and key meetings, minimum 2-3 days a week per Performance with Choice policies.

Basic Qualification

• 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.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Advanced degree (MS, PharmD, PhD, MD, or equivalent) in a scientific discipline.
• 10+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Experience supporting b