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Parexel
Senior Regulatory Affairs Associate, CTA Senior Specialist
Remote · United States · Full time · Senior level
About the role
Support clinical trial authorization submissions and regulatory compliance activities globally. Collaborate cross-functionally to advance new treatments for patients worldwide.
What you’ll do
• Provide operational and regulatory support for CTA submissions. • Prepare and coordinate global CTA and amendment documentation. • Manage submissions to health authorities and regulatory interactions. • Liaise with CROs for submissions and query management. • Implement global CTA strategy and ensure compliance.
What you’ll bring
• Bachelor's degree in Life Science or equivalent. • 6+ years pharmaceutical industry experience. • 5+ years in Regulatory Affairs. • Strong knowledge of EU drug development and CTR. • Excellent communication and project management skills.
Life at Parexel
Offers health, vision, dental insurance, tuition reimbursement, paid time off, 401(k) match, and flexible work-life balance.
About Parexel
Parexel is a global clinical development partner delivering clinical and consulting solutions to the life sciences industry with over 22,000 employees worldwide.