Contract Opportunities

Global Labeling Lead - Senior Regulatory Labeling Consultant

Contract: 52 weeks

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G&L Scientific is seeking a highly experienced Global Labeling Lead/Senior Regulatory Labeling Manager to join our team supporting a global biopharmaceutical client.

This is a long-term opportunity for a seasoned labeling professional with deep technical and regulatory expertise and a proven track record of managing complex global labeling activities across established products.

We are looking for someone who can operate confidently and independently in the “grey areas” of labeling, applying sound regulatory judgment, navigating complex cross-functional situations, and driving labeling activities through to successful outcomes.

This is not a role for someone looking to learn regulatory labeling on the job.

The successful candidate will bring substantial hands-on experience in global labeling, a strong understanding of US and EU labeling requirements, and the confidence to lead discussions and make informed decisions in complex situations.

The Role

As a Global Labeling Lead, you will be accountable for driving and managing labeling activities for assigned products in accordance with established processes, SOPs and governance.

The portfolio will focus primarily on established products, with responsibility spanning global and regional labeling activities, deviation management, implementation oversight and cross-functional collaboration.

You will work closely with global and regional regulatory stakeholders, safety, medical, clinical and other cross-functional teams, as well as CML colleagues who will manage artwork activities.

This is a labeling-focused role with no promotional/advertising responsibilities.

Key responsibilities

You will oversee and execute all aspects of product labeling activities, including:

Create and maintain Aspirational Label Claims (ALC) and Core Data Sheets (CDS).
Prepare, revise and maintain regional Product Information (PI) and labeling texts, including:
- US Prescribing Information (USPI)
- EU/European SmPCs
- Patient-facing product information, as applicable
- Medication Guides and Patient Package Inserts, as applicable
- Instructions for Use (IFU), particularly for programs involving medical devices and human factors studies.
Lead and/or support label negotiations with Health Authorities, as required.
Assess and manage complex labeling issues, applying sound regulatory and scientific judgment.
Manage labeling deviation requests, ensuring timely and successful processing, documentation, tracking and closure in accordance with Health Authority and client timelines.
Provide compliance oversight of local implementation of CDS changes, ensuring appropriate and timely execution.
Maintain product information and labeling data within relevant systems.
Prepare, provide and maintain labeling packages and scenarios.
Drive labeling activities for assigned products, including CDS, USPI and SmPC development and maintenance.
Support the development and revision of US labeling based on available source documentation, including final protocols, safety information and/or Investigator's Brochure (IB), as applicable.
Work closely with CML/artwork teams, providing the required labeling content and guidance while CML manages artwork execution.
Ensure labeling activities are conducted in accordance with applicable processes, SOPs, governance and regulatory requirements.
Contribute to global cross-functional teams and initiatives, taking a leadership role where appropriate.
Provide coaching, knowledge-sharing and subject-matter expertise to colleagues and less experienced labeling professionals.

Requirements

Labeling activities are managed through established enterprise systems and processes, including Veeva Vault RIM.

You will be expected to work confidently within structured labeling workflows and governance frameworks, while applying appropriate judgment where situations are complex or not fully defined.

We are specifically seeking strong, seasoned Senior Regulatory Labeling professionals with deep domain expertise.

You should have:

Significant hands-on experience in regulatory labeling within the pharmaceutical/biopharmaceutical industry.
Extensive experience managing global product labeling, ideally across both US and European requirements.
Strong knowledge of USPI, SmPC, CDS and associated product information.
Experience managing labeling for established/marketed products.
Demonstrated experience with Health Authority labeling negotiations.
Strong understanding of labeling requirements, processes, governance and regulatory expectations.
Experience managing