Sr Associate, North America Label Change Project Coordinator

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 role 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 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

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

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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 business performance and other incentive/recognition programs as part of the offering. The salary range for this role is: $84,076 to $115,604 plus a 8% bonus.

Care to join us. Find out what life at is really like www.haleon.com/careers/

At we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, may be required to capture and report expenses incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at at any stage of the application process, please contact us by sending an email to HR.AmericasSC-CS@haleon.com. Please include the following in your email:

• Use subject line: ‘ Careers: Job Accommodation Request’
• Your Name and contact information
• Requisition ID and Job Title you are interested in
• Location of Requisition (city/state or province/country)
• Description of specific accommodation you are requesting
• Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

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 business performance and other incentive/recognition programs as part of the offering.