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

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