Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Honolulu, HI
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Honolulu, HI. Compensation is not specified for this position, which supports a strategic pharmaceutical partnership. This role provides end-to-end regulatory affairs support, managing planning, documentation, and compliance to ensure successful partnership outcomes across clinical and post-approval activities.
What you'll do
- Maintain U.S.
- regulatory archive logs, conduct GLP reviews, author 1572 waiver requests, draft submission components, and prepare periodic reports.
What we're looking for
- Skills & competencies
- full-timeday shifthonolulu hiparexelregulatory affairsclinicalsubmissioncompliancedocumentationpharmaceuticalonsite
- 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: Other Individual and Family Services. Sector: 62.
Additional details
- Industry sector
- 62
- Industry
- Other Individual and Family Services
- Occupation code
- 11-9121.01
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Listing ID: 2429198b-7629-4560-aa37-d20b610ef227