When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
An incredible opportunity to apply your FDA experience in a way that drives solutions and meaningful impact for clients.
What if your next role allowed you to move beyond observations and actively shape outcomes, influencing compliance strategies and driving lasting improvement across the industry?
At Parexel Consulting, former FDA professionals partner with industry to solve complex compliance challenges, guide strategy, and drive meaningful, lasting improvements across global life sciences organizations.
Parexel Consulting is growing and we are seeking a Principal Consultant with prior FDA experience to join our Strategic Compliance team. This role is designed for senior professionals who have built deep expertise within the FDA and are now interested in applying that experience in a more proactive, solution-oriented environment.
In contrast to a strictly enforcement-focused role, this position provides the opportunity to work directly with clients to identify risks early, solve complex regulatory challenges, and help organizations achieve and sustain compliance—ultimately impacting product quality and patient outcomes.
This opportunity offers a unique transition from regulatory enforcement into strategic advisory work, where you will:
Move beyond identifying observations to helping clients prevent them
Apply your FDA experience to shape compliance strategies before inspections occur
Partner with organizations to resolve complex issues rather than only documenting them
Influence outcomes by guiding remediation, readiness, and long-term quality improvements
Work across a diverse set of companies, products, and global environments
Key Responsibilities
Serve as a senior advisor to clients on FDA regulatory expectations, inspection strategy, and compliance risk mitigation
Lead inspection readiness and mock inspection programs, helping clients prepare with confidence
Apply firsthand FDA knowledge to anticipate inspection findings and proactively address gaps
Advise on and support response strategies for:
Form FDA 483 observations
Warning letters
Import alerts
Regulatory meetings
Consent decrees and enforcement actions
Guide clients through root cause analysis, remediation planning, and sustainable compliance solutions
Provide expertise in risk-based decision-making, including regulatory discretion and supply continuity
Collaborate across cross-functional teams to support complex quality and regulatory engagements
Mentor team members and contribute to building internal expertise
Engage in client discussions and contribute to business development efforts
Experience Required
A proven track record of experience working at the FDA in the Office of Regulatory Affairs (ORA), Office of Inspections and Investigations (OII), and/or Office of Compliance (CDER)
Leadership in domestic and international GMP inspections, including foreign cadre assignments
Experience conducting for-cause, pre-approval, and surveillance inspections
Involvement in high-priority or complex inspections
Direct experience supporting regulatory enforcement actions, including:
Drafting or contributing to Warning Letters
Developing Import Alert recommendations
Participating in recalls, regulatory meetings, or enforcement escalations
Engagement with industry on compliance expectations and post-inspection follow-up
Preferred Technical Expertise
Data Integrity inspections and remediation
Sterile manufacturing / aseptic processing
API and drug product manufacturing across multiple dosage forms
Qualifications
Prior experience with the U.S. Food and Drug Administration in inspection, compliance, or enforcement roles
Demonstrated experience across the inspection and enforcement lifecycle
Strong understanding of GMP compliance and pharmaceutical manufacturing systems
Experience conducting inspections internationally or as part of a foreign inspection cadre
Ability to translate regulatory expectations into clear, actionable solutions for clients
Strong communication and stakeholder engagement skills
Ability to travel 50-70% with a focus on international travel
Education & Experience Requirements
Bachelor’s degree required (life sciences, engineering, public health, or related field)
Advanced degree preferred (e.g., MPH, MS, PhD, MBA)
15+ years of related experience, including significant FDA experience in inspection, compliance, or enforcement roles
What We Offer
Opportunity to move from enforcement to influence, helping organizations proactively meet regulatory expectations
Exposure to complex and high-impact challenges across global life sciences clients
Collaborative consulting environment with leadership and mentorship opportunities
The ability to directly contribute to improving product quality, compliance, and patient safety
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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