Regulatory Affairs Associate

Job Summary

A company is looking for a Regulatory Affairs Associate I.

Key Responsibilities

• Manage low- to medium-complexity regulatory submission projects, ensuring timely delivery of high-quality, agency-ready dossiers
• Provide Regulatory Affairs submissions support to cross-functional teams, advising on submission standards, processes, timelines, and deliverables
• Conduct detailed quality reviews of published submissions to ensure compliance with regulatory standards and health authority guidelines

Required Qualifications

• Bachelor's Degree required
• Two years of pharmaceutical or industry-related experience required
• Preferred experience with publishing-related software tools such as Documentum, eCTDXPress/ISIPublisher, and Adobe Acrobat