Overview
Executive Director, Strategic Labelling — lead global labelling development and governance for GSK's medicines and vaccines. Drive initiation and development of labelling aligned with Target Medicine Profiles (TMP) and Target Vaccine Profiles (TVP) from early lifecycle stages through commercialization. Ensure progress through project milestones and governance processes in compliance with external regulations and GSK standards. Engage with senior stakeholders across R&D, Regulatory, Safety, and Commercial to foster collaboration and innovation in labelling standards.
Responsibilities
- Lead the global labelling process for GSK’s development portfolio through early lifecycle stages.
- Ensure regulatory requirements related to product information and submission strategies are met; proactively resolve issues across therapy areas.
- Provide strategic direction for labelling governance and represent GSK in global labelling committees and industry events.
- Advise senior management and regulatory teams on product labelling policies, standards, and compliance.
- Manage and motivate the Strategic Labelling team (including team leaders and their teams), fostering collaboration and alignment with GSK’s principles.
- Represent GSK in industry groups and during internal and external regulatory inspections or audits related to labelling governance and processes.
Why You?
This role is hybrid with flexibility to work remotely and on-site as required. We value inclusion and welcome applicants from all backgrounds. Below are the basic and preferred qualifications.
Basic Qualifications
- Bachelor's degree in Science, Medicine, or Pharmacy
- Regulatory experience across all phases of the drug development process in a global pharmaceutical company
- Global labelling experience
- People management and matrix leadership experience
Preferred Qualifications
- Advanced degree (MS, PharmD, PhD) in Science, Medicine, or Pharmacy
- Regulatory Affairs strategy experience, preferably in a leadership role
- Deep understanding of multi-regional external regulatory environments
- Proven ability to rapidly assimilate data and resolve complex problems, making recommendations to senior management
- Proven ability to lead global teams, resolve complex regulatory and scientific issues, and influence effectively in a matrix environment
- Strong interpersonal, presentation, and communication skills with established internal and external networks
How to apply
If you are ready to lead labelling strategy that helps bring safe and effective medicines to patients worldwide, we want to hear from you. Apply now and tell us how your experience and values align with this role.
Location considerations: 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 factors including work location within the US market, candidate’s skills, experience, education level, and market rate for the role. This position offers an annual bonus and eligibility to participate in our long-term incentive program. 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.
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. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.
We are committed to creating an environment where our people can thrive, work with purpose, and deliver for patients, shareholders and colleagues alike.
Accessibility and Contact
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at .
GSK is an Equal Opportunity Employer. This ensures all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, or military status.
Important notice to Employment businesses/Agencies: GSK does not accept referrals from employment businesses and/or employment agencies unless prior written authorization is obtained. This is a condition precedent to any agreement with GSK.
For compliance with US transparency requirements, if applicable, GSK may capture and report expenses for interviews. More information is available at the CMS Open Payments data site.
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