Regulatory Affairs Manager

As a Global submission manager at ICON, you will contribute to drug development as part of the Regulatory Affairs team.

This position serves as the regional regulatory representative within study teams, responsible for obtaining and maintaining clinical trial authorizations for compounds in development or marketed products under investigation for new indications

What You Will Do:

You will oversee regulatory affairs workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, ensuring full compliance with local and global regulatory requirements.

• Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines.

• Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations.

• Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure timely submissions, approvals, and updates for ongoing clinical studies.

• Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs.

• Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in assigned region, and proactively communicate implications to project teams.

• Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation.

• Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across regions.

• Provide mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and maintenance.

• As agreed with regional or global regulatory management, may provide support for clinical trial submissions and maintenance activities in other countries within the assigned region.

Your Profile:

You will have solid global regulatory affairs experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline 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