Sr Associate, North America Label Change Project Coordinator

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

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

• Minimum 3 years of experience in a labeling-related role (e.g. pharma or OTC CPG artwork, labeling, project management, etc)

• 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.

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Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program.  This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave.  On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family.  We also offer the opportunity to receive a discretionary bonus based on the achievement of key bu