Director, Regulatory Operations at ICON plc

What you will be doing

• Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
• Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
• Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
• Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
• Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.

Your profile

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of global regulatory requirements and guidelines.
• Proven track record of successful regulatory submissions and approvals.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
• Proven leadership experience