Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Lincoln, NE
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist role is an onsite position based in Lincoln, NE. Compensation is not specified. This role supports a strategic pharmaceutical partnership and its associated development and commercial programs. This position serves as a key regulatory interface, responsible for regulatory planning, documentation management, submission execution, and ensuring ongoing compliance with global regulatory requirements. The associate works cross-functionally to maintain operational excellence across clinical, submission, and post-approval activities.
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, prepare presentation materials for Global Regulatory Team meetings, and manage post-approval regulatory reports.
What we're looking for
- Skills & competencies
- full-timeday shiftlincoln neparexelregulatory affairsclinicalsubmissioncompliancedocumentationpharmaceuticalno weekendsno on-call
- 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: 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: 7f2c5b7a-9bf4-4223-8bec-dac009b26369