Senior Regulatory Affairs Associate - Generalist

Job overview

The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Tallahassee, FL, with compensation not specified. This role supports Parexel's strategic pharmaceutical partnerships by providing end-to-end regulatory affairs support for development and commercial programs. The role exists to ensure regulatory excellence across clinical, submission, and post-approval activities. It contributes to the team by managing documentation, preparing regulatory submissions, and ensuring compliance with global regulatory requirements to support successful partnership outcomes.

What you'll do

• Maintain U.S.
• regulatory archive logs.
• Ensure compliance using RIM/EDMS systems.
• Author 1572 waiver requests.
• Attend cross-functional clinical trial team meetings.
• Draft administrative components of regulatory submissions.
• Build electronic submission structures.
• Prepare presentation materials for Global Regulatory Team meetings.
• Prepare and submit periodic post-marketing reports.

What we're looking for

Skills & competencies

full-time

day shift

tallahassee fl

regulatory affairs

pharmaceutical

clinical trials

compliance

documentation

project management

parexel

Work arrangement

• Weekend coverage required

Why this role

3+ years of regulatory affairs experience required; Bachelor's degree in a scientific or technical discipline required.

About the employer

Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.