Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Pierre, SD
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Pierre, SD, with compensation not specified. This position supports Parexel's pharmaceutical partnerships by providing end-to-end regulatory affairs support. The role exists to ensure regulatory excellence across clinical, submission, and post-approval activities. By managing documentation and coordinating with regulatory authorities, the associate ensures that development programs remain compliant with global requirements.
What you'll do
- Maintain U.S. regulatory archive logs
- provide clinical regulatory support
- draft administrative components of submissions
- prepare materials for Global Regulatory Team meetings
- contribute to drafting and reviewing regulatory submissions
- prepare post-marketing reports.
What we're looking for
- Skills & competencies
- full-timeday shiftpierre sdparexelregulatory affairspharmaceuticalcomplianceclinical trialsdocumentationsubmissionno on-callno travel
- Work arrangement
- Weekend coverage required
Benefits & perks
- Comprehensive benefits package.
Why this role
Requires 3+ years of regulatory affairs experience; candidates in Eastern/Central time zones preferred.
About the employer
Parexel is hiring for this role. Industry: Administration of Veterans' Affairs. Sector: 92.
Additional details
- Industry sector
- 92
- Industry
- Administration of Veterans' Affairs
- Occupation code
- 11-9121.01
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Listing ID: c655280d-fd6a-4d18-bd0a-b142551d45a6