Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Boise, ID
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Boise, ID. Compensation is not specified for this position, which supports a strategic pharmaceutical partnership and its associated development and commercial programs. This role exists to provide end-to-end regulatory affairs support, ensuring operational excellence in regulatory planning, documentation management, submission execution, and global compliance for assigned pharmaceutical products.
What you'll do
- Maintain U.S.
- regulatory archive logs, conduct GLP reviews of study documentation, author 1572 waiver requests, draft administrative components of regulatory submissions, and prepare periodic post-marketing regulatory reports.
What we're looking for
- Skills & competencies
- full-timeday shiftboise idparexelregulatory affairsclinical regulatorydocumentation managementsubmission preparationpost-approval maintenanceonsite
- Work arrangement
- Weekend coverage required
Why this role
Requires 3+ years of regulatory affairs experience and a Bachelor's degree in a scientific or technical discipline.
About the employer
Parexel is hiring for this role. Industry: Other Individual and Family Services. Sector: 62.
Additional details
- Industry sector
- 62
- Industry
- Other Individual and Family Services
- Occupation code
- 13-1041.07
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Listing ID: de9fe402-2284-4c5b-99c8-9d4884e206fd