Senior Regulatory Affairs Consultant - Regulatory Lead

Parexel; Honolulu (HI); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading global consulting firm is seeking a Regulatory Affairs Strategy Lead in Honolulu, Hawaii. The ideal candidate will have over 7 years of regulatory experience within pharma or biotech, leading multidisciplinary teams and designing regulatory strategies. This role involves overseeing submissions and collaborating with Health Authorities to influence critical development programs. Flexible work arrangements are offered.

Benefits

Flexible work arrangements

Collaborative culture

Cutting-edge regulatory tools and training

Qualifications

• 7+ years of regulatory experience in pharma or biotech.
• Proven success design and execution of regulatory strategies for NCEs and biologics.
• Deep knowledge of FDA, ICH, and global regulatory frameworks.
• Experience with international clinical trials and regulatory documentation.

Responsibilities

• Lead regulatory strategy for assigned programs from early development through approval.
• Coordinate cross-functional regulatory activities to meet key milestones.
• Conduct Regulatory Risk Assessments and guide teams through complex decision-making.
• Prepare and oversee global submissions in eCTD format.

Skills

Regulatory strategy design

Leadership

Problem-solving

Collaboration

Strong communication

Education

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

Job description

Overview

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.

Responsibilities

• 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

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.