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Manager, Regulatory Affairs to join our diverse and dynamic team. You will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team. You'll provide regulatory guidance and operational support across various stages of drug development, including early development, agency interactions, clinical trial applications, marketing applications, and post-approval staff.
Job Responsibility:
Lead regulatory activities and submissions independently
Provide regulatory guidance and efforts to internal teams
Participate in agency interactions and regulatory submissions
Contribute to developing best practices within ICON Regulatory Affairs
Work collaboratively as part of a regulatory or cross-functional team
Requirements:
Bachelor's degree in a scientific or healthcare-related field
advanced degree preferred
Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
Prior experience with various regulatory submissions, including CTA/IND/MAA
Ability to lead internal teams and carry out regulatory activities independently
Strong understanding of global regulatory requirements and guidelines