Director, Global Regulatory Affairs Lead (Oncology)

About the role

The role is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff and may also involve individual support for projects as a regional director or Global Regulatory Lead (GRL). The role reports directly to the GRS TG Portfolio Lead.

The Regulatory Director/Team Leader, along with the respective Portfolio Lead, is responsible for:

• Provision of adequate resources to support the various development programs within the respective portfolio.
• Ensuring the development and effective execution of regulatory strategies for assigned assets, aligned with the Medicines Development Strategy and the Integrated Evidence Strategy (IES), to fulfill the requirements of key markets as identified and the Medicine Profile.

All regulatory activities and line management must be carried out in strict compliance with internal GSK processes and policies, as well as with applicable regulatory requirements.

Leadership Responsibilities

• Management of direct reports, including mentoring/coaching, guidance on regulatory strategies, and adherence to internal and external standards.
• May also provide individual support for projects as a regional director or GRL.

Responsibilities

• Accountable to the GRS TG Portfolio Lead and TG VP for developing and delivering appropriate regulatory strategies, with planning on a multi-year horizon and extensive matrix collaboration within GSK.
• Works with the Portfolio Lead and TG VP to ensure robust regulatory strategies and appropriate TG resources (including recruitment) are in place to support development programs.
• Develops, coaches, and mentors individuals within the team, including performance assessment and management.
• May serve as a regional director or GRL for select assets.

When a Team Lead (as applicable):

• Provides direct line management responsibility for TG staff.
• Attracts, challenges, manages, and develops direct reports.
• Manages performance (e.g., My Plan, Reward, Recognition, PIPs).
• Drives resource demands, workforce planning, and budget management.
• Understands and drives resource management conversations, including new assignments and gap identification.

When a Global Regulatory Lead (GRL) (as applicable):

• Works with Early/Medicine Development Teams (EDT/MDT) to ensure a robust regulatory strategy is in place.
• Collaborates with global commercial and local regulatory teams to secure optimal labeling.
• Proactively develops regulatory strategies and promotes innovative approaches.
• Assesses regulatory precedent, intelligence, and competitive environment to shape strategy.
• Leads regulatory interactions and review processes.
• Ensures compliance with regulatory requirements throughout the product lifecycle.
• Advocates for strategies to senior leaders in GSK and Health Authorities.
• Acts as a single point of accountability on the EDT/MDT, leading the Regulatory Matrix Team and delivering required Regulatory Work Packages.

When a Regional Director (as applicable):

• Accountable for regional and/or global regulatory strategies and delivery.
• Serves as the single point of contact for assigned assets, responsible for regional/global strategy.
• Works closely with local/regional commercial teams to secure optimal labeling.
• Leads interactions with local/regional regulatory authorities.
• Ensures the regulatory strategy meets local and global needs.
• Implements regional strategies in support of global projects.
• Ensures compliance with regional requirements at all stages of the product lifecycle.
• Advocates persuasively to senior leaders in GSK and Health Authorities.
• Provides critical regulatory assessments for due diligence/business development.

Leadership

• Fosters strong matrix collaboration and facilitates group solutions for regulatory strategies.
• Manages cultural diversity and leads global teams effectively.
• Leads change, communicates difficult messages, and revises processes to reduce barriers.
• Builds strong personal networks within and outside GSK to secure project support.
• Focuses on performance improvement and challenges existing processes for excellence.

Business Skills

• Delivers clear, impactful, and audience-tailored communication using a range of techniques.
• Adapts personal style to different audiences and proactively addresses potential issues.
• Derives creative solutions to regulatory problems while balancing agency expectations and compliance.
• Synthesizes complex information globally to assess the "big picture" for projects.
• Makes sound decisions with incomplete information or under time constraints.
• Demonstrates strong business acumen and understanding of competitive landscapes.
• Influences and manages conflict in a consensus-building manner.
• Builds and maintains external networks to shape the regulatory environment.
• Recognized internally and externally as an expert in specific areas of regulatory strategy.

Technical Skills

• Ability to interpret regulatory authority data and advice objectively, even amid competing views.
• Strong development and clinical/scientific acumen, with a good understanding of diseases and medicines being developed.
• Awareness of the role of digitalization in development and regulatory strategy to enhance decision-making and innovation.

Compliance

• Clear understanding of the importance of following all applicable laws, regulations, and GSK expectations.

Qualifications

Basic 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.
• Experience leading Health Authority interactions, including preparation, execution, and follow-up for regulatory milestone meetings.
• Experience working on cross-functional development teams (Clinical, Safety, Commercial, Statistics, CMC, etc.).
• Experience assessing and applying regulatory precedent, intelligence, and evolving requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets (U.S., EU, or other international jurisdictions).
• Experience ensuring compliance with regulatory requirements, industry standards, and company policies.

Preferred Qualifications

• Advanced degree (PhD, MD, PharmD, or relevant master’s) in biology, Life Sciences, or Healthcare Sciences.
• Experience in resource management and forecasting.
• Experience in all phases of drug development in regulatory affairs, including projects with little or no precedence.
• Knowledge of relevant therapeutic areas or a proven track record of product development.
• Knowledge of clinical trial and licensing requirements in priority markets and globally.
• Experience leading regulatory activities outside the local region.
• Experience as a Global Regulatory Lead or equivalent leadership role.

Skills

• Business Resilience
• Communication
• Digital Fluency
• Matrix Leadership
• Pharmaceutical Regulatory Compliance
• Regulatory Strategies
• Resource Management
• Stakeholder Management

Pay

For candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for this position ranges from $171,750 to $286,250. The salary range accounts for factors such as work location, skills, experience, education level, and market rate for the role.

This position also offers an annual bonus and eligibility to participate in a share-based long-term incentive program, dependent on the role level.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays, vacation, and paid caregiver/parental and medical leave.