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ICON Strategic Solutions · 5 days ago

Regulatory Affairs Manager

United States

Full-time

Remote

Senior Level

6+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are currently seeking a Manager, Regulatory Affairs to contribute to drug development by providing regulatory guidance and operational support across various stages of drug development.

Responsibilities

Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA

Provide regulatory guidance and efforts to internal teams

Participate in agency interactions and regulatory submissions

Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines

Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Qualification

Regulatory submissionsRegulatory guidanceGlobal regulatory requirementsPharmaceutical industry experienceLeadership

Required

Bachelor's degree in a scientific or healthcare-related field

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

Preferred

advanced degree preferred

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.