Senior Regulatory Affairs Associate - Generalist

Job overview

The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Dover, DE, providing end-to-end regulatory support for pharmaceutical development and commercial programs. This position supports a strategic pharmaceutical partnership by ensuring regulatory excellence across clinical, submission, and post-approval activities, with compensation not specified in the posting. This role serves as a key regulatory interface, managing documentation, submission execution, and compliance with global requirements. It exists to ensure operational excellence and regulatory alignment, contributing to the successful delivery of partnered assets through cross-functional collaboration and proactive risk management.

What you'll do

• Maintain U.S. regulatory archive logs and correspondence
• conduct GLP reviews of study documentation
• author 1572 waiver requests
• draft administrative components of regulatory submissions including FDA forms and cover letters
• prepare presentation materials for Global Regulatory Team meetings
• support post-approval regulatory maintenance including PADERs and DSURs.

What we're looking for

Skills & competencies

full-time

day shift

dover de

regulatory affairs

pharmaceutical

clinical

compliance

documentation

submission

onsite

parexel

no on-call

no weekends

Work arrangement

• Weekend coverage required

Why this role

Requires 3+ years of regulatory affairs experience; preference for candidates in Eastern or Central time zones.

About the employer

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