Senior Regulatory Affairs Associate - Generalist
Employment type
Full-time
Work setting
On-site
Location
Providence, RI
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Providence, RI. Compensation is not specified for this position, which supports a strategic pharmaceutical partnership. This role exists to provide end-to-end regulatory support for clinical and commercial programs. It contributes to the partnership's goals by ensuring regulatory excellence, compliance, and operational efficiency in submission and post-approval activities.
What you'll do
- Maintain U.S.
- regulatory archive logs.
- Author 1572 waiver requests.
- Draft administrative components of regulatory submissions.
- Prepare presentation materials for Global Regulatory Team meetings.
- Support post-marketing regulatory reports.
What we're looking for
- Skills & competencies
- full-timeday shiftprovidence riparexelregulatory affairspharmaceuticalcompliancesubmissiononsiteclinical development
- Work arrangement
- Weekend coverage required
Benefits & perks
- Equal opportunity employer.
Why this role
Requires 3+ years of regulatory affairs experience.
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
- 11-9199.01
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Listing ID: 78ff3930-f732-4fec-a8d1-e704a670f93f