I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Consultant - Clinical Regulatory Affairs (Part-Time)
Primary Location: United States, Remote Job ID R0000041088 Category Regulatory Affairs Date Posted 04/22/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
At Parexel, we are driven by a single purpose: to partner with our clients and help patients get access to life‑changing therapies faster.
We are currently seeking a part-time Regulatory Affairs Consultant to join a dedicated client partnership. In this role, you’ll play a critical role in making that mission real—guiding complex clinical studies through the regulatory landscape with rigor, insight, and collaboration.
As a part-time Regulatory Affairs Consultant, you will be the strategic regulatory leader driving compliance and health authority strategy for a major pharmaceutical client's clinical portfolio. This is a dedicated partnership role with strong client trust and visibility to senior regulatory and clinical leadership.
This role focuses on regulatory strategy, health authority engagement, and compliance oversight—not site-level study coordination or patient-facing activities.
What You'll Do
Develop and execute regulatory strategies for clinical development programs
Lead health authority interactions and manage regulatory submissions (IND applications, annual reports, safety submissions)
Conduct regulatory impact assessments and risk analysis
Provide regulatory expertise on complex compliance issues
Serve as the regulatory authority within cross-functional teams
Ensure adherence to ICH guidelines and global regulatory pathways
Required Qualifications
Minimum 5+ years of experience in regulatory affairs, with demonstrated expertise in health authority strategy and regulatory submissions to include deep understanding of regulatory strategy and health authority engagement.
Strong knowledge of clinical development regulations
Proven experience with IND applications, annual reports, and safety submissions (IND 120, IND 130, etc.)
Strong knowledge of ICH guidelines and global regulatory pathways
Familiarity with electronic submission systems (e-STARs, etc.)
Ability to work independently on regulatory matters with minimal supervision
Strong written and verbal communication skills
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree strongly preferred
Knowledge of FDA Regulations and previous experience with FDA meeting requests and other packages.
Experience with other global Health Authorities and applicable regulations are strongly preferred
Why This Role
Serve as the regulatory leader for a major pharma client with direct visibility to senior regulatory and clinical leadership
Deepen your expertise in health authority strategy and regulatory submissions
Work in a dedicated partnership model with strong client trust
Part-time flexibility to balance professional development with other commitments
If you're passionate about regulatory strategy and want to make an impact at the health authority level, we'd love to hear from you.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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