# Director, Global Regulatory Strategy- Oncology

**Company**: GSK
**Location**: Upper Providence, Pennsylvania
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $171,750 to $286,250
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director-Global-Regulatory-Strategy--Oncology_450964?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_bfac795e-dab

## Description

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.

**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.

**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**

- 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 business development, licensing, acquisitions, or due diligence activities.

- Experience leading regulatory activities across multiple geographic regions.

- Experience managing regulatory professionals in a global matrix environment.

- Experience incorporating digital, AI-enabled, or data-driven approaches into regulatory strategy or decision-making.

**Work Arrangement** This role is hybrid, based in the United States. You will be expected to attend leadership activities and key meetings regularly on-site. Remote-first candidates within the US may be considered if they can travel as needed.

**Salary** The annual base salary for new hires in this position ranges $171,750 to $286,250.

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## Skills

### Required
- Pharmaceutical Regulatory Compliance
- Regulatory Strategies
- Resource Management
- Stakeholder Management
- Communication
- Digital Fluency
- Matrix Leadership

### Nice to have
- Experience supporting business development, licensing, acquisitions, or due diligence activities
- Experience leading regulatory activities across multiple geographic regions
- Experience managing regulatory professionals in a global matrix environment
- Experience incorporating digital, AI-enabled, or data-driven approaches into regulatory strategy or decision-making

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