Global Regulatory Affairs Associate
Eurofins
AssemblyVault
Senior Regulatory Affairs Consultant – Regulatory Lead
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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
Requirements
- 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
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyregulatory risk assessmentsglobal submissionsINDsCTAseCTD formattechnical document reviewIMPD preparationNCEsbiologics
Soft skills
communicationleadershipcollaborationdetail-orientedproblem-solving
