Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Lansing, MI
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Lansing, MI, with compensation not specified. This position provides end-to-end regulatory support for pharmaceutical development and commercial programs. This role exists to ensure regulatory excellence and compliance across clinical, submission, and post-approval activities. The associate manages documentation, prepares regulatory submissions, and collaborates with cross-functional teams to support successful partnership outcomes.
What you'll do
- Maintain U.S.
- regulatory archive logs.
- Author 1572 waiver requests.
- Prepare administrative components of regulatory submissions.
- Support Global Regulatory Team meetings.
- Manage post-approval regulatory maintenance.
What we're looking for
- Skills & competencies
- full-timeday shiftlansing miparexelregulatory affairspharmaceuticalclinicalonsitecompliancedocumentation
- Work arrangement
- Weekend coverage required
Why this role
Requires 3+ years of regulatory affairs experience.
About the employer
Parexel is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Research and Development in Biotechnology (except Nanobiotechnology)
- Occupation code
- 11-9199.01
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Listing ID: 1978be1f-992c-4515-b7dc-729029d0ffb3