Senior Regulatory Affairs Associate - Generalist

Job overview

The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Cheyenne, WY. Compensation is not specified for this position, which supports a strategic pharmaceutical partnership at Parexel, a global clinical development partner. This role exists to provide end-to-end regulatory affairs support for partnered assets, ensuring regulatory excellence across clinical, submission, and post-approval activities. The associate will work cross-functionally to manage documentation, submission execution, and compliance with global regulatory requirements.

What you'll do

• Maintain U.S. regulatory archive logs
• provide clinical regulatory support including 1572 waiver requests
• prepare and organize regulatory submissions
• serve as the Regulatory Affairs representative in partner meetings
• manage post-approval regulatory maintenance and reporting.

What we're looking for

Skills & competencies

full-time

day shift

cheyenne wy

parexel

regulatory affairs

pharmaceutical

compliance

submission management

clinical regulatory

no on-call

project management

Work arrangement

• Weekend coverage required

Benefits & perks

• Professional development, collaborative team environment, comprehensive benefits package.

Why this role

Focus on strategic pharmaceutical partnerships, end-to-end regulatory support, cross-company collaboration, preference for Eastern/Central time zone candidates.

About the employer

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