2026 Co-Op: Regulatory Affairs (12 months, January 2026 start)
2026 Co-Op: Regulatory Affairs (12 months, January 2026 start)
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Job Description
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 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.
To enable you to perform in this future talent opportunity:
Basic Requirements:
- Enrolled in bachelors 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.
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Employment Type
Full-Time
