Sr Associate, North America Label Change Project Coordinator

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

About the Role

The Sr Associate, North America Label Change Project Coordinator is responsible for coordination of US and Canada labeling activities and artwork brief preparation, including serving as a key point of contact for cross-functional teams and the Global Artwork Center of Excellence (COE).

Role Responsibilities

This Regulatory Affairs Operations & Compliance role is responsible for labelling activities of assigned brands including:

Artwork – US and Canada

• Coordination of artwork brief preparation

  • Support the business by representing the artwork process on project team meetings and through tracking labeling timelines

  • Initiation of artwork changes in Artwork Management System (CHAMPS)

  • Collection of market sources in CHAMPS (regulatory sources, design, claims)

  • Verification that final artwork aligns with sources provided

  • Provide annotations to Artwork COE for urgent health authority requests

  • Support audits and inspections

Regulatory Content Documents (RCDs) - US

• Performing independent review in document management system (Veeva RIM Vault), including general proofreading for spelling and grammar and compliance with local regulatory requirements

Websites – US

• Coordination of updates for labelling and safety content for US websites including:

  • Triaging reviews and approvals with Medical and Regulatory Strategists

  • Providing new or revised labeling

  • Assisting with special requests including audit and inspection support

• Assisting in reviewing content and verifying accuracy as needed

Structured Product Labelling (SPL) – US

• Performing independent review of SPLs using electronic proofing tools

General

• Manage priorities and timelines to ensure timely delivery according to process and project timelines

• Responsible for up to 3 categories/brands totaling about 500 changes responsible per year, attributing to £500,000 (GBP) in revenues

• Prioritize and escalate when necessary

• Resolve conflicts, ensure data integrity

• Assist with research or other assignments to support Operations and Compliance activities in the US/PR

• Actively participate and share ideas with the team for best practices, process improvements, and enhanced efficiencies

• Contribute to the wellbeing of Haleon through positive teamwork and cross-functional partnerships

Why you?

Basic Qualifications:

• Bachelor’s Degree and minimum 3 years of experience in a labeling-related role (e.g. pharma or OTC CPG artwork, labeling, project management, etc), or combination of education and experience

• Experience working on cross-functional teams

• Experience with cGMPs

Preferred Qualifications:

• Advanced degree in project management, business, quality or scientific disciplines; RAC

• Experience working on global teams

• Project management experience

• Experience in document management, including Veeva and/or an artwork management system

• SAP

• Knowledge of US regulations: CFR and labeling guidance documents

Location: This role is based in Warren, NJ. This role has in-office requirements of minimum 3 days per week.

Compensation: The salary range for this role is: $84,076 to $115,604  plus a 8% bonus.

#Li-Hybrid

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program.  Thi