Senior Regulatory Affairs Consultant - Regulatory Lead

Regulatory Affairs Strategy Lead

Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs? Do you thrive in cross-functional environments and love transforming regulatory requirements into actionable plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be the driving force behind regulatory strategy and execution for some of our clients' most critical development programs. These are high-impact roles where you'll lead multidisciplinary teams, shape global submission strategies, and serve as a key liaison with Health Authorities.

What You'll Do

• Lead regulatory strategy for assigned programs from early development through approval
• Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical) to meet key milestones
• Conduct Regulatory Risk Assessments and guide teams through complex decision-making
• Prepare and oversee global submissions, including INDs, CTAs, and marketing applications in eCTD format
• Respond to Health Authority questions during IND / NDA review phases
• Review and approve technical documents across Clinical, Nonclinical, and CMC domains
• Monitor evolving regulations and translate changes into internal SOPs and process improvements
• Collaborate with Regulatory Operations to ensure eCTD compliance and submission readiness
• Support international trials through IMPD preparation and CTA strategy

What You Bring

Why You'll Love Working Here

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.