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Senior Regulatory Affairs Consultant - Regulatory Lead
Primary Location: United States, Remote Job ID R0000035930 Category Regulatory Affairs Date Posted 10/08/2025Overview
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
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 United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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