2026 Co-Op: Regulatory Affairs (12 months, January 2026 start)

Role Summary

12-month Co-Op in US Regulatory Affairs starting January 2026. Support process improvements and efficiencies within Regulatory Affairs and help maintain electronic data management systems, FDA correspondences, and submission information for Haleon’s portfolio.

Responsibilities

• Track and categorize FDA eCTDs and submissions across Haleon NDAs to clearly outline submission details in one location
• Track, categorize, and upload FDA correspondences in the regulatory archival location (eDMS) for easy retrieval
• Maintain registration metadata and confirm accuracy of metadata
• Support management of open objectives and change events through closure
• Categorize FDA questions/correspondence by topic across all INDs and NDAs to identify themes and trends
• Support migration of FDA questions/correspondence to the eDMS
• Retrieve and consolidate historical regulatory documents and assessments on pertinent projects
• Work within 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

Qualifications

• Enrolled in a bachelor‚Äôs degree program in Science, Biology, Pharmacy, or related field
• Experience with Microsoft Word and Excel; eDMS experience preferred
• Detail oriented with ability to manage multiple tasks concurrently
• Available to work full-time (40 hours/week) Monday‚ÄìFriday 8am‚Äì5pm for 12 months
• GPA of 3.0 or higher preferred
• Eligible to work in the US for duration of employment; evidence of US work authorization required
• Must not require future sponsorship for an employment visa
• On-site in Warren, NJ

Skills

• Regulatory affairs knowledge across FDA submissions and lifecycle management
• Proficiency with document management systems and submission tracking
• Strong organizational and analytical skills
• Ability to categorize and track regulatory correspondence by topic
• Effective communication and ability to present insights to a team

Education

• Bachelor‚Äôs degree pursuit in Science, Biology, Pharmacy, or related field

Additional Requirements

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