Senior Regulatory Affairs Consultant - Regulatory Lead

Join Parexel as a 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

B.S. in a scientific discipline (M.S. preferred)

7+ years of regulatory experience in pharma or biotech in a similar role

Proven success designing and executing regulatory strategies for NCEs and biologics

Deep knowledge of FDA, ICH, and global regulatory frameworks

Experience with international clinical trials and regulatory documentation

Strong communication, leadership, and collaboration skills

Detail-oriented mindset with a proactive approach to problem-solving

Willingness to travel 15-20%, if needed, in a global work environment

Why You'll Love Working Here

Work with both passionate, mission-driven colleagues and client teams

Influence global development programs that make a difference

Enjoy flexible work arrangements and a collaborative culture

Stay ahead of the curve with cutting-edge regulatory tools and training

Be part of a company that values innovation, integrity, and impact

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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 US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.