Executive Director - Strategic Labelling

GSK•Cambridge, MA

9d•Hybrid

About The Position

We are seeking an experienced and dynamic Executive Director, Strategic Labelling to lead global labelling development and governance for GSK's diverse portfolio of medicines and vaccines. This role is pivotal in driving the initiation and development of labelling aligned with Target Medicine Profiles (TMP) and Target Vaccine Profiles (TVP) from early lifecycle stages through to commercialization. You will ensure labelling progresses seamlessly through project milestones and governance processes, while maintaining compliance with external regulations and GSK standards. The role offers an exciting opportunity to engage with senior stakeholders across R&D, Regulatory, Safety, and Commercial functions, fostering collaboration and innovation in labelling standards. The ideal candidate will bring strong leadership skills, deep expertise in regulatory affairs, and a commitment to delivering impactful labelling solutions that support GSK’s portfolio and global health initiatives.

Requirements

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

Nice To Haves

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.

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 resolving 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.