New · posted Nov 11
GSK · Pharmaceuticals
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology
- Upper Providence, PA
- Hybrid
- Full-time
- Director
The role
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:
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.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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.
Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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.
What you need
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Regulatory Strategies, Resource Management, Stakeholder Management• 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. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers 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, and 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 205,000Belgium Salary Range / Fourchette salariale – Belgique: EUR 141,750 to EUR 236,250The 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. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of 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.
Preferred Qualificationsnice to have
- 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.
Apply Now
If this role aligns with your experience and career goals, we encourage you to apply. Tell us how you will contribute to labelling excellence and help improve outcomes for people with cancer.
Pay and benefits
$221,925 – $369,875 a year
Employer providedHealth care and insurance benefits
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Annual bonus
Where you'll work
Upper Providence, PAHybridOpen in Maps (opens in a new tab)
More jobs in Upper Providence, PA
From the posting
About GSK
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.
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 - [email protected]
Equal opportunity, accessibility and legal noticesGSK's statements, word for word
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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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 44% above the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $221,925 | — | $369,875 |
| All US (middle half) | $198,500 | $205,500 | $227,500 |
This role: GSK's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 82 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not GSK's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions3
- GMP and compliance2
- Documentation and SOPs2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Labeling & Promotion work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 202(official source, opens in a new tab)Prescription drug advertising: fair balance and required information
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
- FDAFDA prescription drug labeling resources(official source, opens in a new tab)Physician Labeling Rule (PLR) format and content of prescribing information
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- CMSOpen Payments (Sunshine Act)(official source, opens in a new tab)Reporting of manufacturer payments to physicians and teaching hospitals
- HHS-OIGHHS-OIG General Compliance Program Guidance(official source, opens in a new tab)The federal government's guide to healthcare compliance programs and the anti-kickback statute
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
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- Open roles
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- 8
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By discipline
- Clinical19 49%
- Quality14 36%
- Regulatory6 15%
By level
- Director21 54%
- Associate & Specialist8 21%
- Manager4 10%
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Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology at GSK
Applications close November 13. $222K–$370K a year, employer provided.