About The Position

Haleon is a world-leading consumer healthcare company with exceptional category-leading brands, including Sensodyne, Centrum, Panadol, and Otrivin. We are looking for a Co-Op student in US Regulatory Affairs to join us and do career-defining work. The Regulatory Affairs team plays a critical role in managing product lifecycle, ensuring compliance with FDA requirements, and providing business advice on regulatory changes. The Co-Op Associate will support process improvements and efficiencies within Regulatory Affairs, ensuring compliance in our electronic data management system (eDMS) and managing product registrations and FDA correspondences.

Requirements

  • Enrolled in a bachelor’s degree program studying Science, Biology, Pharmacy, or related field.
  • Experience working in Microsoft Word and Excel and eDMS (preferred).
  • Detail-oriented with the ability to manage multiple tasks simultaneously.
  • Must be able to work full-time (40 hours/week) Monday-Friday 8am-5pm for 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.
  • Applicant must not require future sponsorship for an employment visa status.

Responsibilities

  • Support process improvements and efficiencies within Regulatory Affairs.
  • Ensure compliance in the electronic data management system (eDMS).
  • Manage accurate status of documents and closure of open change events.
  • Categorize FDA correspondences and update associated metadata.
  • Work in submission management software on New Drug Application (NDA) products.
  • Track and categorize FDA eCTDs across Haleon NDAs.
  • Maintain registration metadata and confirm accuracy.
  • Support management of open objectives and change events.
  • Categorize FDA questions/correspondence by topic.
  • Retrieve and consolidate historical regulatory documents.

Benefits

  • Hourly Rate: $24.50/hour
  • Opportunity to learn about FDA submission documentation.
  • Visibility to various types of submissions and FDA correspondences.
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