Senior Regulatory Affairs Associate - Generalist

Job overview

The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Jefferson City, MO. Compensation is not specified. This role supports a strategic pharmaceutical partnership at Parexel. This role exists to provide end-to-end regulatory support for partnered assets. The associate ensures regulatory excellence across clinical, submission, and post-approval activities by managing documentation and maintaining compliance with global requirements.

What you'll do

• Maintain U.S.
• regulatory archive logs and manage correspondence.
• Author 1572 waiver requests and support clinical regulatory documentation.
• Draft administrative components of regulatory submissions including FDA forms and cover letters.
• Serve as the Regulatory Affairs representative in partner meetings.
• Prepare and submit periodic post-marketing regulatory reports.

What we're looking for

Skills & competencies

full-time

day shift

jefferson city mo

parexel

regulatory affairs

pharmaceutical

clinical trials

fda

compliance

documentation

Work arrangement

• Weekend coverage required

Why this role

Supports strategic pharmaceutical partnerships and global regulatory teams.

About the employer

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