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

Glaxosmithkline; Rockville (MD); Híbrido; USD 222.000 - 370.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Long-term share-based incentive

Health insurance and family benefits

Retirement benefits

Paid holidays and vacation

Parental and medical leave

Descripción de la vacante

GSK is seeking a Sr Director and Team Lead for Regulatory Labelling Strategy and Development in Oncology. You will lead a global team, shape compliant and patient-focused labelling, and partner with R&D, Safety, Regulatory, and Commercial to align strategies.

The role offers hybrid work with on-site collaboration and opportunities to influence labeling standards, timelines, and regulatory submissions across therapeutic areas.

Formación

• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Experience leading global labelling development and regulatory interactions.

Responsabilidades

• Manage, train, and motivate a team of global labelling professionals for the oncology portfolio.
• Accountable for management of the labelling process from development through early lifecycle management.
• Ensure compliance with regulatory requirements and collaborate with matrix teams to resolve issues.
• Provide strategic direction for labelling governance issues and serve on Global Labelling Committee.
• Advise Regulatory and senior management on labelling issues across R&D, Safety, Regulatory and Commercial.
• Engage with Regulatory Authorities to drive innovative labelling approaches.

Conocimientos

Business resilience

Communication

Digital fluency

Matrix leadership

Pharmaceutical regulatory compliance

Policy advocacy

Regulatory strategies

Resource management

Stakeholder management

Educación

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

Advanced degree (MS, PharmD, MD, or PhD)

Descripción del empleo

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

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

• 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

• 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 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.

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 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.

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 - [e-mail]

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.