Director, Labelling Strategy & Development, Therapeutic Area Lead

GSK•Upper Providence, PA

1d•Hybrid

About The Position

This role directs Global delivery and early lifecycle labelling development and Governance for an assigned Therapeutic Area (e.g., Oncology, Vaccines or Specialty products). It holds 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 is 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 the assigned Therapeutic Area and providing advice to GSK teams on Global Labelling Committee (GLC) requirements/processes and on global labelling requirements. The role is accountable for engaging with senior stakeholders in R&D, Regulatory, ViiV, Safety, and Commercial to ensure effective development of GSK labels and compliance with external regulations and expectations. Close liaison with the Global Labelling function within GRA is essential for cohesive and aligned end-to-end labelling approaches for the assigned portfolio. The job holder is accountable for providing innovative approaches/recommendations for product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.

Requirements

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.

Nice To Haves

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.

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.