Senior Regulatory Affairs Associate – Generalist

Parexel

Regulatory Affairs Generalist at Parexel supporting pharmaceutical partnerships and compliance activities. Focused on regulatory submissions and documentation management for clinical and post-approval processes.

Posted 6/2/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Provide end‑to‑end regulatory affairs support for partnered assets
Maintain U.S. regulatory archive logs
Support cross-functional clinical trial team meetings
Draft administrative components of regulatory submissions
Prepare, review, and submit periodic post marketing regulatory reports
Maintain tracking and compliance with global post approval commitments

Requirements

What you’ll need

3+ years of related regulatory affairs experience in an industry-related environment.
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsregulatory submissionspost marketing regulatory reportscompliance trackingregulatory archive management

Soft Skills

cross-functional collaborationcommunicationorganizational skills