Labelling Strategy and Development, Oncology Team Lead

GSK

10d•Hybrid

About The Position

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 As a therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team for oncology products. You will engage with key stakeholders across R&D to ensure effective development of GSK oncology labels. You will shape labelling that is clear, compliant, and supports patient care and product success. We value collaborative leaders who communicate clearly, build trust with stakeholders, and deliver practical regulatory solutions. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Requirements

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.

Nice To Haves

Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
Experience in oncology therapeutic areas and familiarity with oncology clinical data and endpoints.
Prior direct experience interacting with regulatory reviewers.
Experience aligning labelling strategy with commercial and medical affairs objectives.
Track record of developing patient-focused labeling and plain-language content.
Experience mentoring colleagues and building capability within a labelling or regulatory team.
Strong knowledge of regulatory requirements for prescription product labelling and safety reporting.
Proven ability to lead cross-functional teams and manage complex review processes and timelines.
Clear written and verbal communication skills, with experience drafting regulatory documents and communicating with regulators.

Responsibilities

Manage, train, and motivate a team of global labelling professionals for the oncology portfolio.
Accountable for management of the GSK labelling process for the development portfolio from early development through to early lifecycle management.
Ensure compliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner.
Provide strategic direction for labelling governance issues for assigned therapeutic area and serve on Global Labelling Committee.
Advise Regulatory and senior management on issues relating to product labelling, interfacing with senior leaders across R&D, Safety, Regulatory and Commercial to develop, implement, and maintain policies and standards.
Engage with Regulatory Authorities in areas impacting labelling standards and policies directly or collectively through professional organizations to drive innovative labelling approaches.