2026 Regulatory Affairs Co-Op (6 months, July 2026 Start)
Warren, OH - USA
Job Summary
Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve 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 its 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.
Hi. Were 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. Thats an incredible opportunity. An exciting challenge. And a huge responsibility. Were 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 were looking for a 6-month 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 products 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.
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.
To enable you to perform in this future talent opportunity:
Minimal Requirements:
Ability to start by July 1 2026
Enrolled in bachelors degree program studying in Science Biology Pharmacy or related field graduating between December 2026 and May 2028
Experience working in Microsoft Word and Excel and eDMS (preferred)
Candidate must be able to work full-time (40 hours/ week) Monday-Friday 8am-5pm for duration of 6 months
A cumulative GPA of 3.0 is preferred
The selected candidate will need to be on site at Haleon (Warren NJ or Berkeley Heights NJ)
Live in NJ or provide your own funding for relocation and commuting to the office.
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.
Expected start date: July 2026
The hourly rate for this role is $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.
Job Posting End Date
Equal Opportunities
Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.
During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.
The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.
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 Haleons 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 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
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Please note: Resumes CVs or other requests outside of accommodation support submitted to this email box will not be accepted.
Note to candidates
The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.
Key Skills
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.