Parexel
Senior Regulatory Affairs Consultant - Regulatory Lead
Parexel, Frankfort, Kentucky, United States, 40601
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 phasesReview 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.
#J-18808-Ljbffr
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 phasesReview 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.
#J-18808-Ljbffr