Senior Regulatory Affairs Generalist — Remote

Parexel; Nashville (TN); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support strategic pharmaceutical partnerships in the US. You will handle end-to-end regulatory planning, documentation management, and submissions for clinical, submission, and post-approval activities.

The role requires 3+ years in regulatory affairs, a scientific/technical degree, and strong communication skills. Remote work is possible with preference for US Eastern/Central time zones.

Qualifications

• 3+ years of regulatory affairs experience in an industry-related environment.
• Bachelor’s degree in a scientific or technical discipline; advanced degree preferred.
• Location in US Eastern or Central time zones preferred.

Responsibilities

• Regulatory archiving and documentation management for assigned programs, ensuring audit readiness.
• Clinical regulatory support, including GLP reviews and IND-related tasks.
• Draft and oversee regulatory submissions and related documents.
• Participate in Global Regulatory Team meetings and alliance discussions.
• Author and review submissions across development stages and regulatory designations.
• Prepare post-approval regulatory reports and maintain lifecycle commitments.

Skills

Project management

Client-focused

Results orientation

Teamwork

Consulting

Interpersonal communication

Critical thinking

English proficiency

Education

Bachelor’s degree in scientific/technical discipline

Advanced degree preferred

Job description

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support strategic pharmaceutical partnerships in the US. You will handle end-to-end regulatory planning, documentation management, and submissions for clinical, submission, and post-approval activities.

The role requires 3+ years in regulatory affairs, a scientific/technical degree, and strong communication skills. Remote work is possible with preference for US Eastern/Central time zones.