Senior Director, Team Lead – Regulatory Labelling Strategy and Development, Oncology

GSK

. Lead a global labelling team for oncology products.

Posted 11/10/2026full-timeUnited StatesSenior💰 $221,925 - $369,875 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading global labelling teams within the oncology sector, ensuring compliance with regulatory requirements and developing patient-focused labelling strategies. Proven ability to interface with regulatory authorities and align labelling strategies with commercial objectives.

Highest-signal resume keywords

Regulatory Affairs ExperienceOncology Labelling DevelopmentCross-Functional Team LeadershipRegulatory Compliance KnowledgePatient-Focused Labelling

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labelling Strategy DevelopmentRegulatory Document DraftingOncology Clinical Data FamiliaritySafety Reporting KnowledgeComplex Review Process Management

Soft Skills

Clear Communication SkillsMentoring and Training AbilityProactive Issue Resolution

Certifications & Qualifications

Bachelor’s Degree in Life SciencesAdvanced Degree (MS, PharmD, MD, or PhD) Preferred

Industry Keywords

Pharmaceutical IndustryBiotech IndustryGlobal Labelling CommitteeRegulatory AuthoritiesLabelling Governance

About the role

Key responsibilities & impact

Lead a global labelling team for oncology products.
Manage, train, and motivate global labelling professionals for the oncology portfolio.
Manage the GSK labelling process for the development portfolio from early development through early lifecycle management.
Ensure compliance with regulatory requirements related to product information and submission strategy.
Work with matrix teams to resolve issues proactively.
Provide strategic direction for labelling governance issues in the assigned therapeutic area.
Serve on the Global Labelling Committee.
Advise Regulatory and senior management on product-labelling issues.
Interface with senior leaders across R&D, Safety, Regulatory, and Commercial to develop, implement, and maintain policies and standards.
Engage with Regulatory Authorities regarding labelling standards and policies, directly or through professional organizations, to drive innovative labelling approaches.

Requirements

What you’ll need

Bachelor’s degree in life sciences, pharmacy, medicine, or related field.
At least 5 years of regulatory affairs or labelling experience in the pharmaceutical or biotech industry with line and matrix leadership experience.
3+ years of experience leading global labelling development, submissions, or regulatory interactions.
Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline preferred.
Experience in oncology therapeutic areas and familiarity with oncology clinical data and endpoints preferred.
Prior direct experience interacting with regulatory reviewers preferred.
Experience aligning labelling strategy with commercial and medical affairs objectives preferred.
Track record of developing patient-focused labeling and plain-language content preferred.
Experience mentoring colleagues and building capability within a labelling or regulatory team preferred.
Strong knowledge of regulatory requirements for prescription product labelling and safety reporting preferred.
Proven ability to lead cross-functional teams and manage complex review processes and timelines preferred.
Clear written and verbal communication skills, with experience drafting regulatory documents and communicating with regulators preferred.

Benefits

Comp & perks

Annual bonus
Eligibility to participate in share-based long-term incentive program
Health care and other insurance benefits for employee and family
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Comprehensive benefits program
Accommodation or other assistance to apply, if required