Senior Regulatory Affairs Partner – Remote

Parexel; Charleston (WV); On-site; USD 90,000 - 140,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership, handling end-to-end regulatory activities across clinical, submission, and post-approval work. The role collaborates with internal teams and alliance stakeholders to ensure regulatory excellence.

You will manage archiving, submissions, and cross-functional regulatory planning, attend alliance meetings, and contribute to lifecycle regulatory maintenance for assigned programs.

Qualifications

• 3+ years of regulatory affairs experience in an industry-related environment.
• Bachelor’s Degree in a Scientific or Technical Discipline required; Advanced Degree preferred.

Responsibilities

• Regulatory Archiving & Documentation Management: Maintain U.S. regulatory archive logs, record new submissions, archive authority correspondence, manage partner correspondence, ensure proper indexing and audit readiness.
• Clinical Regulatory Support: Maintain trackers for Form FDA 1572, perform GLP reviews, author 1572 waivers, support routine clinical submissions, attend cross-functional trial team meetings as Regulatory Affairs representative.
• Regulatory Submission Preparation: Draft administrative submission components, build electronic submission structures, manage workflows, coordinate delivery with publishing teams.
• Global Regulatory Team & Cross-Functional Collaboration: Prepare GRT materials, represent Regulatory Affairs in alliance meetings, support cross-functional program meetings.

Skills

Project management

Client-focused

Results orientation

Teamwork

Consulting

Interpersonal communication

Critical thinking

English proficiency

Education

Bachelor’s degree in a Scientific or Technical Discipline

Job description

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership, handling end-to-end regulatory activities across clinical, submission, and post-approval work. The role collaborates with internal teams and alliance stakeholders to ensure regulatory excellence.

You will manage archiving, submissions, and cross-functional regulatory planning, attend alliance meetings, and contribute to lifecycle regulatory maintenance for assigned programs.