Senior Regulatory Affairs Generalist – Global Submissions

Parexel; Tallahassee (FL); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel seeks a highly organized Regulatory Affairs Generalist / Senior Associate to support end-to-end regulatory activities for partnered assets, spanning clinical, submission, and post-approval work.

The role acts as regulatory interface within the alliance, coordinating documentation, submissions, and cross-functional teams to ensure regulatory excellence in a dynamic, multi‑stakeholder environment.

Qualifications

• 3+ years regulatory affairs experience in pharma/biotech.
• Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred.

Responsibilities

• Maintain US regulatory archive logs, record new submissions, and manage authority correspondence.
• Prepare 1572 waiver requests and support regulatory submissions for clinical investigators.
• Draft administrative components of regulatory submissions and manage submission structures in RIM/EDMS.
• Serve as regulatory liaison in cross-functional clinical trial teams with regulatory updates and risk assessments.
• Prepare post-approval regulatory materials (PADERs, NDA Annual Reports, DSURs, PBRERs).

Skills

Project management

Client focus

Results oriented

Teamwork

Consulting

Communication

Critical thinking

English proficiency

Education

Bachelor's in science/tech

Advanced degree preferred

Job description

Parexel seeks a highly organized Regulatory Affairs Generalist / Senior Associate to support end-to-end regulatory activities for partnered assets, spanning clinical, submission, and post-approval work.

The role acts as regulatory interface within the alliance, coordinating documentation, submissions, and cross-functional teams to ensure regulatory excellence in a dynamic, multi‑stakeholder environment.