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Hi. We’re Haleon. A world-leading consumer healthcare company with exceptional category-leading brands – including Sensodyne, Centrum, Panadol, Otrivin. We have a clear purpose: **to deliver better everyday health with humanity** . For billions of people around the globe.

Early Talent roles at Haleon offer the chance to change the way people see and manage their everyday health. That’s an incredible opportunity. An exciting challenge. And a huge responsibility. We’re always looking for ambitious individuals who are inspired by our purpose to deliver better everyday health, with humanity. And want to help us achieve this goal. Right now, we’re looking for a Co-Op student in US Regulatory Affairs to join us to do career defining work.

A career in Regulatory Affairs where none of us stand still.

Regulatory Affairs plays an important role across many industries. Within Consumer Healthcare, Regulatory Affairs works with legislation covering pharmaceuticals, medical devices, cosmetics and foods. The Regulatory Affairs team helps to guide our company on our responsibility for discovery, testing, manufacture, and marketing. Our goal is to continuously supply products that are of proven safety, efficacy, and quality as part of our worthwhile contribution to public health and welfare.

Regulatory Affairs plays a critical role in managing product lifecycle, starting from a product’s development to its availability in the market. We are educated on the regulations, employ thoughtful strategies, and coordinate with multiple departments to achieve a product fit for the public. Regulatory Affairs continuously needs to monitor for external changes being introduced in our category landscapes. We then provide business advice on impact to products and contribute as part of cross-functional teams to implement any changes to ensure the product complies with the updated legislation.

Having a complete and accurate historical record of regulatory correspondence is critical as our team supports:

+ facilitating current compliance with FDA requirements

+ driving efficiency by sharing learnings across programs

+ accelerating innovation through translational knowledge, and

+ identifying emerging regulatory trends and evolving FDA expectations.

The Regulatory Affairs Co-Op Associate

The objective of the Regulatory Affairs Co-Op Associate role will be to support process improvements and efficiencies within Regulatory Affairs. This role will be instrumental in supporting routine system maintenance and ensuring compliance in our electronic data management system (eDMS) through:

+ ensuring that product registrations are accurate,

+ supporting maintenance of objectives,

+ managing accurate status of documents, and

+ managing closure of open change events.

This role will also support ensuring our eDMS accurately contains the history of our products through categorizing our FDA correspondences, updating the associated metadata and uploading and classifying older FDA correspondences.

This role will also be accountable for working in our submission management software on our New Drug Application (NDA) products to capture historical information on submission content, FDA information requests and correspondences to leverage the historical information, documentation and correspondences to drive future innovation. A comprehensive file with details from our submission management system (TRS), inclusive of legacy organization documents and submissions outlined will be extremely useful for Haleon and providing visibility to potential gaps.

In this role, the Co-Op Associate will be provided with the opportunity to learn about FDA submission documentation, as well as a high-level overview of regulatory components for both Investigational New Drugs (INDs) and New Drug Applications (NDAs) across the Haleon portfolio. The role will also provide the candidate with visibility to various types of submissions and FDA correspondences. This is an opportunity to learn about the structure of the electronic Common Technical Document (eCTD), which is an industry wide format used for submissions to the FDA.

The Regulatory Affairs Co-Op will be responsible for the following activities to ensure that Haleon has a complete, accurate, and easily accessible historical record of FDA correspondences, FDA Information Requests, and submission documentation for the Haleon portfolio:

+ Track and categorize FDA eCTDs via the submission management system) across Haleon NDAs to clearly outline submission details in one location

+ Track, categorize, and upload FDA Correspondences in appropriate regulatory archival location (eDMS) for easy retrieval

+ Maintain registration metadata and confirm accuracy of the metadata.

+ Support management of open objectives and change events through closure

+ Categorize the FDA questions/correspondence by topic across all INDs and NDAs for a consolidated catalogue of the Agency questions to identify themes and emerging trends

+ Support migration of FDA questions/correspondence in the Health Authority database to the eDMS

+ Retrieve and consolidate historical regulatory documents and assessments on pertinent projects.

**To enable you to perform in this future talent opportunity** :

Basic Requirements:

+ Enrolled in bachelor’s degree program studying in Science, Biology, Pharmacy, or related field

+ Experience working in Microsoft Word and Excel and eDMS (preferred)

+ Detail oriented and ability to manage multiple tasks simultaneously

+ Candidate must be able to work full-time (40 hours/ week) Monday-Friday 8am-5pm for duration of 12 months

+ A cumulative GPA of 3.0 is preferred

+ Must be eligible to work in the US at the time of, and for the duration of employment

+ Employees will be required to furnish evidence of US work authorization.

+ Applicant must not require future sponsorship for an employment visa status.

+ The selected candidate will need to be on site in Warren, NJ

What will your individual contribution at Haleon be?

The expectation for the Regulatory Affairs Co-Op Associate will be as follows:

+ Work within the Haleon systems (eDMS and submission tracking system) to retrieve archived FDA documentation and correspondences and ensure proper classification

+ Utilize Haleon archival systems (eDMS) to upload and properly store FDA correspondences

+ Maintain registration metadata for accurate product registration details.

+ Prepare and maintain detailed spreadsheets to capture the chronological history of FDA information for specific programs

+ Track and share meaningful and organized progress

+ Present to the team a summary of insights from review of historical FDA documentation, identifying themes and emerging trends to help characterize FDA expectations for future regulatory submissions.

**Expected start date:** January 2026

**Hourly Rate for this role will be:** $24.50/hour

We invite you to apply as soon as possible. The way we see it, every day is an opportunity. And we are joined by new talent, every day.** **We accept ongoing applications and will close this vacancy once we have enough applications.

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

At Haleon 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.

Haleon 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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s 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 Haleon at any stage of the application process, please contact us by sending an email to [email protected]. Please include the following in your email:

+ Use subject line: ‘Haleon 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.

Hello. We’re Haleon. A new world-leading consumer healthcare company. Shaped by all of us. Together, we’re improving everyday health for millions 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 building together. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.