Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Trenton, NJ
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Trenton, NJ. Compensation is not specified for this position, which supports Parexel's strategic pharmaceutical partnerships by providing end-to-end regulatory affairs support. This role exists to ensure regulatory excellence across clinical, submission, and post-approval activities. The incumbent will manage documentation, prepare regulatory submissions, and collaborate with cross-functional teams to maintain compliance with global regulatory requirements.
What you'll do
- Maintain U.S. regulatory archive logs
- author 1572 waiver requests
- prepare regulatory submission components
- support Global Regulatory Team meetings
- manage post-approval regulatory reports
- ensure audit readiness.
What we're looking for
- Skills & competencies
- full-timeday shifttrenton njregulatory affairspharmaceuticalcompliancedocumentationparexelno salary statedonsite
- Work arrangement
- Weekend coverage required
Benefits & perks
- Parexel offers a comprehensive benefits package including health, vision, dental, and professional development.
Why this role
Focuses on regulatory generalist support for partnered pharmaceutical assets.
About the employer
Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Administrative Management and General Management Consulting Services
- Occupation code
- 11-9121.01
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Listing ID: d105fe26-e006-4600-9824-cdaea305c356