Regulatory Submissions Manager

Exciting Opportunity at Fortrea!

Fortrea is offering a dynamic opportunity to contribute to client-focused delivery through meaningful collaboration between peers and stakeholders within Site Readiness to ensure alignment and efficiency throughout the project lifecycle.

This position is ideal for a regulatory start up professional who thrives in a collaborative environment and is driven by the opportunity to make a significant impact in clinical research.

Main Responsibilities

• Regulatory Oversight & Submissions: Lead and manage RA, IRB/EC, and Third Body submissions, including planning, strategy, tracking, and responding to queries to meet timelines and ensure alignment with project milestones.

• Compliance & Documentation: Ensure regulatory deliverables meet applicable regulations and client requirements by preparing, reviewing, and maintaining core study documents as well as compilation and distribution of the core package and review of the country-specific packages throughout the study lifecycle.

• Regulatory Guidance & Liaison: Provide expert regulatory advice to project teams and clients, stay updated on evolving legislation, support interactions with authorities, and advise on EU CTR/CTIS as applicable.

• Project Management & Risk Oversight: Monitor project progress against budget and timelines, escalate risks proactively, support audits/inspections, and contribute to continuous quality and process improvements.

• Collaboration & Development: Participate in internal and external meetings, support business development efforts, contribute to SOP and process enhancements, and mentor or coach other Site Readiness team members.

Qualifications (Minimum Required):

• Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations.

Experience (Minimum Required): 
• Minimum of 5 years’ experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development. Requested experience in Cell and Gene therapy studies.
• Excellent communication, organization, and planning skills with an attention to detail. 
• Direct supervisory and project management skills and ability to work independently.

Benefits:
At Fortrea, we value our team members and offer a comprehensive benefits package, including competitive compensation, health and wellness programs, and opportunities for professional growth. You’ll also enjoy flexible work arrangements and the chance to make a meaningful impact in cutting-edge clinical research.

Your contribution to Fortrea’ s success:
In this role, you will help ensure the smooth execution of clinical trials and play a key role in delivering high-quality data and compliance. Your efforts will contribute directly to Fortrea’s mission of advancing clinical research and improving global health outcomes. Ready to make an impact? Join us!

micol.iafrate@fortrea.com

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