I contribute to clinical research with expertise and empathy. And I do it
Senior / Principal Regulatory Compliance Consultant
Primary Location: United States, Remote Job ID R0000039657 Category Regulatory Affairs Date Posted 03/11/2026Overview
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
Work With Heart, Lead with Impact
At Parexel, With Heart is more than a core value—it’s how we approach every project, partnership, and patient impact. We bring deep scientific expertise together with empathy, integrity, and genuine human connection. Our consultants don’t just guide clients through compliance challenges; they become trusted partners helping sterile drug manufacturers deliver safe, effective therapies to people worldwide.
If you’re driven by quality, purpose, and the belief that your work should truly matter, this is a unique opportunity to make a global impact across multiple organizations—with heart.
Why This Role Is Exceptional
This isn’t a traditional industry role. It’s an opportunity to:
Amplify your influence by supporting multiple manufacturing sites and teams.
Accelerate your career through diverse, high‑visibility consulting engagements.
Apply your microbiology and aseptic expertise where it matters most—on the front lines of sterile drug product safety.
See more, learn more, and contribute more than in any single-company role.
Travel globally and gain exposure to varied technologies, cultures, and regulatory expectations.
Join a team that values people, not just deliverables, and genuinely supports your growth.
If you thrive in fast-paced environments, enjoy problem‑solving, and want to directly influence product quality and patient safety, you’ll love consulting at Parexel.
Position Overview
The Senior / Principal Regulatory Compliance Consultant serves as a high-level subject matter expert in QC Microbiology and aseptic sterile drug product manufacturing. You will lead complex client engagements, provide hands-on technical and regulatory support, and drive sustainable quality and contamination control improvements.
Candidates must bring 10+ years of progressive QC Microbiology supervisory or management experience in a sterile drug product environment. Prior consulting experience is a plus—not a requirement. We are excellent at transforming seasoned industry leaders into outstanding consultants.
This role requires up to 70% domestic and international travel to support client sites.
Key Responsibilities
You will have the opportunity to:
Serve as a trusted expert in:
QC Microbiology operations and laboratory leadership
Aseptic processing and sterile drug manufacturing
Contamination Control Strategies (CCS)
Environmental Monitoring (EM) programs
Microbial identification, trending, investigations, and CAPA oversight
Water systems, cleaning/disinfection, and sterility assurance
Lead high-impact projects, including:
Designing or optimizing EM, APS, AOQ, and CCS programs
Supporting facility expansions, lab startups, and method qualifications
Conducting regulatory readiness assessments and mock inspections
Authoring and reviewing SOPs, risk assessments (HACCP, FMEA), validation protocols, and technical documentation
Leading investigations using root cause analysis principles
Partner with client leadership to:
Strengthen quality systems aligned with FDA, EMA, ICH, USP, and global standards
Coach microbiology and manufacturing teams on aseptic best practices
Drive compliance improvements that enhance operational reliability and inspection outcomes
Build sustainable, risk-based programs that reduce deviations and contamination events
You will be the person clients turn to when they need expert guidance, clear solutions, and leadership under pressure.
Required Qualifications
10+ years QC Microbiology experience, including supervisory or managerial responsibility
Deep experience supporting aseptic manufacturing of sterile drug products
Expertise in EM, CCS, APS, water systems, sterility assurance, and microbiology lab operations
Strong working knowledge of global regulations (FDA 21 CFR 210/211, EMA Annex 1, ICH, USP)
Proven ability to lead investigations, CAPAs, risk assessments, and data trending
Excellent communication skills with the ability to influence and educate teams
Ability to travel up to 70% domestically and internationally
Preferred Qualifications
Prior consulting experience
Experience with facility startup, remediation, or major operational readiness efforts
ASQ CQA or similar certification
Experience preparing for and supporting FDA/EMA regulatory inspections
Strong experience authoring technical or regulatory documentation
What We Offer
A meaningful mission—improving patient safety across global manufacturing sites
High-impact work with major biopharma and sterile drug product companies
A culture of support, collaboration, and empathy—true to our “With Heart” value
Consulting development and mentorship, including structured support for those new to consulting
Flexibility—remote work when not on client site, plus variety in daily responsibilities
Ready to Make a Global Impact?
If you’re looking for a role where your microbiology expertise, leadership skills, and dedication to patient safety can truly change lives—and you want to do it with heart—we’d love to review your application.
Apply today and bring your expertise to clients around the world—helping them make the sterile products patients rely on safer, one batch at a time.
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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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