Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology

1925 GlaxoSmithKline LLC; Upper Providence (Delaware County); Hybrid; USD 222,000 - 370,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation

Parental and medical leave

Job summary

GSK is seeking a therapeutic head within Labelling Strategy and Governance to lead a global oncology labelling team. You will shape clear, compliant labelling and align with R&D stakeholders to support patient care and product success.

Ideal candidates have senior regulatory experience, cross-functional leadership, and a track record in developing patient-focused labeling. This hybrid role offers visible impact and opportunities to advance global labelling standards.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, medicine, or related field.
• At least 5 years of regulatory affairs or labelling experience in pharma/biotech with line and matrix leadership.
• 3+ years leading global labelling development, submissions, or regulatory interactions.

Responsibilities

• Manage, train, and motivate a team of global labelling professionals for the oncology portfolio.
• Oversee labelling process for development portfolio from early development to early lifecycle.
• Ensure regulatory compliance and work with matrix teams to resolve issues proactively.
• Provide strategic direction for labelling governance and serve on Global Labelling Committee.
• Advise Regulatory and senior management on labelling issues with cross-functional interfacing.
• Engage with Regulatory Authorities to drive innovative labelling approaches.

Skills

Cross-functional leadership

Regulatory affairs

Labelling strategy

Stakeholder management

Regulatory compliance

Education

Bachelor’s degree in life sciences, pharmacy, medicine, or related field

Advanced degree (MS, PharmD, MD, or PhD) in a relevant discipline

Job description

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:

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.

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.

Basic Qualifications

• 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.

Preferred Qualifications

• 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.

Work Arrangement

This role is hybrid with regular on‑site collaboration expected. Typical schedule will be 2 to 3 days on‑site per week.

What we value in you

We seek candidates who are collaborative, curious, and accountable. You should enjoy solving regulatory challenges and building trusted relationships. You should be comfortable making clear recommendations and balancing scientific, regulatory, and commercial considerations. We welcome people who bring different perspectives and life experiences, and who will help us create an inclusive environment where everyone can do their best work.

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Regulatory Strategies, Resource Management, Stakeholder Management

Salary and Benefits

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $221,925 to $369,875.

There is an annual bonus and eligibility to participate in our share‑based long‑term incentive program which is dependent on the level of the role.

Available benefits include

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave

If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Italian Salary Range / Fascia retributiva in Italia: EUR 123,000 to EUR 205,000

Belgium Salary Range / Fourchette salariale – Belgique: EUR 141,750 to EUR 236,250

The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role.

More detailed information on the total benefits package will be supplied during the recruitment process.

This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Accessibility

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail].

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important Notice to Employment Businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Compliance and Transparency

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.

This role is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.