Senior Regulatory Affairs Associate - Generalist (Onsite)
Employment type
Full-time
Work setting
On-site
Location
Denver, CO
Schedule
Day shift
Posted
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Job overview
The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Denver, CO. Compensation is not specified, and this role supports the regulatory affairs team at Parexel. This role exists to provide end-to-end regulatory support for pharmaceutical partnerships, ensuring compliance and excellence across clinical, submission, and post-approval activities.
What you'll do
- Maintain regulatory archives
- support clinical regulatory documentation
- prepare submission components
- collaborate with global teams
- author regulatory submissions
- manage post-approval reports.
What we're looking for
- Skills & competencies
- full-timeday shiftdenver coparexelregulatory affairspharmaceuticalcomplianceclinicalgeneralistonsite
- Work arrangement
- Weekend coverage required
Benefits & perks
- Comprehensive benefits package provided by Parexel.
Why this role
Requires 3+ years of regulatory affairs experience; Bachelor's degree in Scientific or Technical Discipline; strong project management skills.
About the employer
Parexel is hiring for this role. Industry: Other General Government Support. Sector: 92.
Additional details
- Industry sector
- 92
- Industry
- Other General Government Support
- Occupation code
- 11-9121.01
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Listing ID: aeaa9616-84ac-4306-bc18-df8418686f76