GSK

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

GSK$221K — $369K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in life sciences, pharmacy, medicine, or related field.
  • 5-7 years of regulatory affairs or labelling experience in the pharmaceutical/biotech industry.
  • 3+ years of experience leading global labelling development and submissions.
  • Advanced degree (MS, PharmD, MD, or PhD) preferred but not required.
  • Strong knowledge of regulatory requirements for prescription product labelling and safety reporting.

Responsibilities

  • Manage, train, and motivate a global labelling team for oncology products.
  • Oversee the GSK labelling process from early development through lifecycle management.
  • Ensure compliance with regulatory requirements and proactively resolve issues.
  • Provide strategic direction on labelling governance for the oncology therapeutic area.
  • Advise senior management on product labelling matters and interface with key leadership across departments.
  • Engage with Regulatory Authorities to advocate for innovative labelling approaches.

Benefits

  • Comprehensive health insurance options.
  • Flexible work arrangements with a hybrid model.
  • Professional growth and development opportunities.
  • Supportive culture of collaboration and accountability.
  • Commitment to diversity, inclusion, and the well-being of employees.
Full Job Description

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 portfoliofrom early development through to early lifecycle management.
  • Ensurecompliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner.
  • Providestrategic direction for labelling governanceissues for assigned therapeutic areaand serve onGlobal Labelling Committee.
  • AdviseRegulatory and seniormanagement on issues relating to product labelling, interfacingwith senior leaders across R&D,Safety, Regulatory and Commercial todevelop, implement, andmaintainpolicies and standards.
  • Engagewith Regulatory Authorities in areasimpactinglabelling standards and policies directly or collectively through professionalorganizationsto 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:

  • Bachelor27s 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 andmatrixleadership 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.

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.


Skills

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 candidate27s 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 6 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 candidate27s 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 candidate27s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate27s 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.

About GSK

GSK is a British multinational pharmaceutical company that specializes in researching, developing, and manufacturing a wide range of prescription drugs and vaccines. The company was founded in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham. GSK's products are used to treat a variety of conditions including respiratory diseases, HIV/AIDS, and cancer. The company operates in over 150 countries and has a workforce of over 99,000 employees. GSK is headquartered in Brentford, England and is listed on the London Stock Exchange and the New York Stock Exchange.
Learn more about GSK
Size
90,096 employees
Market Cap
$71.6 billion
Industry
Net Income
$5.7 billion
Founded
1929
5 Year Trend
+4.1%
Revenue
$34 billion
NASDAQ

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