Co-Op, Regulatory Affairs Associate (12-months, January 2025 Start)

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. 

Future 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 Co-Ops student in Regulatory Affairs to join us to do career defining work.

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

Regulatory Affairs Overview

Regulatory Affairs plays an important role across many industries.  Within Consumer Healthcare, Regulatory Affairs works with legislation covering pharmaceuticals, medicinal devices, cosmetics and foods.  The regulatory affairs team ensure companies responsible for discovery, testing, manufacture and marketing of products continuously supply products that are of proven safety, efficacy and quality, and make a worthwhile contribution to public health and welfare.

Regulatory Affairs plays a critical role in managing the product life cycle, starting from development process to its availability in the market by using strategies and coordinating with multiple departments to achieve a product fit for the public.  Regulatory Affairs continuously needs to monitor for changes being introduced, provide advice on impact to products and strategies on implementing the necessary changes to ensure the product complies with the updated legislation.

Having a complete and accurate historical record of regulatory correspondence is critical:

• Facilitates compliance with FDA requirements
• Drives efficiency by sharing learnings across programs
• Allows the acceleration of innovation through translational knowledge
• Enables the identification of emerging regulatory trends and evolving FDA expectations

Regulatory Affairs Co-Op

The objective of the Regulatory Affairs Co-Op role will be to provide a systematic review and categorization of archived Food and Drug Administration (FDA)  regulatory correspondences and other documents.  This role will be instrumental in providing an efficient way to access this information and will provide a central file of all documentation and the ability to leverage the historical information, documentation and correspondence to drive future innovation.  Creating a comprehensive file, inclusive of legacy organization documents, will

be extremely useful for Haleon.

This role will provide the Associate with the opportunity to learn about FDA submission documentation, and a high-level overview of regulatory components for both Investigational New Drugs (INDs) and New Drug Applications (NDAs) across the Haleon portfolio.  It will also provide visibility to various types of submissions and FDA correspondences.  This role will also provide 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 documentation for identified Haleon products: 

• Track and categorize FDA eCTD submissions across all Haleon INDs and NDAs to clearly outline submission details.
• Track, categorize and upload FDA Correspondences in appropriate regulatory archival location (i.e. Veeva) for easy retrieval.
• Track and categorize FDA paper-based submissions located in hard copy in secured areas of Haleon corporate (sites), as well as third party off site archival storage.
• Categorize the FDA questions by topic across all INDs and NDAs for a consolidated catalogue of the Agency questions to identify themes and emerging trends.
• 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 Associate role will be as follows:

• Work within the Haleon systems (Veeva and TRS) to retrieve archived FDA documentation and correspondences.
• Utilize Haleon archival systems (Veeva) to upload  and store FDA correspondences.
• Prepare and maintain detailed spreadsheets to capture the chronological history of FDA information for specific programs.
• Present to USRA team a summary of insights from review of historical  FDA documentation, identifying themes and emerging trends to help characterize FDA expectations for future regulatory submission.

To enable you to perform in this future talent opportunity:

Minimal Requirements: 

• Enrolled in bachelor’s degree program studying in Science, Biology, Pharmacy or related field
• Experience working in Microsoft Word and Excel.
• 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.
• Ability to start in January 2025.
• Provide your own funding for relocation and commuting.
• This role is onsite at our Warren, NJ location.
• 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.

Expected start date:  January 2025

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/