Director, Labelling Strategy & Development, Therapeutic Area Lead

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.

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Our approach to R&D
 

Position Summary
Direct Global delivery and early lifecycle labelling development and Governance for assigned Therapy Area (e.g., Oncology, Vaccines or Specialty products). The role will have accountability for the initiation and development of labelling, in alignment with the Target Medicines Profile (TMP) and Target Vaccines Profile (TVP), for assets from Commit to Phase 2 to early lifecycle. A key accountability will be ensuring the development of labelling through project milestones and through Tier 1 and Tier 2 labelling governance. This includes line accountability and oversight of processes for authoring of global product information (Global PI) for assigned Therapeutic Area and provision of advice to GSK teams on Global Labelling Committee (GLC) requirements/ processes and on global labelling requirements.  The role will have accountability for engaging with senior stakeholders in R&D, Regulatory, ViiV, Safety, and Commercial to ensure effective development of GSK labels and ensuing compliance with external regulations and expectations. Close liaison with the Global Labelling function within GRA will also be key to ensure cohesive and aligned end to end labelling approaches for the assigned portfolio. The job holder will be accountable for providing innovative approaches/recommendations for product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.

Responsibilities

• Accountable for management of the GSK labelling process for the development portfolio through to early lifecycle.
• Ensures all regulatory requirements (e.g., related to product information, submission strategy) are met and work with Matrix Teams to resolve any issues in a proactive manner. Ensures compliance with laws and regulations.
• Provides strategic direction for Labelling Governance issues for assigned Therapeutic Area and serve on Global Labelling Committee and/or ViiV Safety and Labelling Committee (as appropriate).
• Advises 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.
• Line manages, recruits, and motivates staff within assigned Therapeutic Area Strategic Labelling function.
• May be active in external facing activities and is effective at representing GSK in various industry groups (such as DIA) or at EMA- or FDA-sponsored events (e.g., Workshops, Advisory Committees).
• Engages with Regulatory Authorities in areas impacting labelling standards and policies directly or collectively through professional organisations 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.

Preferred Qualifications

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

• 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.

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.

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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.

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