Strategic Regulatory Affairs Lead – Remote

Parexel; Springfield (IL); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership across development and commercial programs. You will serve as a regulatory interface, guiding planning, documentation, submissions, and ongoing compliance for partnered assets.

In a dynamic, cross‑functional environment, you will balance multiple priorities, coordinate with internal teams and alliance stakeholders, and contribute to regulatory excellence from clinical through

Qualifications

• 3+ years of related regulatory affairs experience in the pharmaceutical industry.

Responsibilities

• Maintain U.S. regulatory archive logs and submissions.
• Support clinical regulatory documentation and IND compliance.
• Draft and coordinate regulatory submission components and FDA forms.
• Prepare for cross-functional alliance meetings and regulatory governance.
• Ensure post-approval regulatory maintenance and timely reporting.

Skills

Project management

Client-focused

Results orientation

Teamwork

Consulting

Interpersonal communication

Critical thinking

English proficiency

Education

Bachelor's Degree in Science/Technical

Tools

RIM systems

EDMS

Job description

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership across development and commercial programs. You will serve as a regulatory interface, guiding planning, documentation, submissions, and ongoing compliance for partnered assets.

In a dynamic, cross‑functional environment, you will balance multiple priorities, coordinate with internal teams and alliance stakeholders, and contribute to regulatory excellence from clinical through