Manager, Regulatory Clinical Applications

Role Summary

Manager, Regulatory Clinical Applications — supports planning and execution of clinical trial application (CTA) activities across global studies, coordinating with CROs, internal teams, and regulators to ensure timely and compliant study startup and maintenance. Remote work in the United States is possible.

Responsibilities

• Support the Director in coordinating and implementing study startup activities in collaboration with CROs and internal study teams.
• Assist in identifying country-specific regulatory and ethics committee requirements to facilitate timely CTA approvals.
• Review and prepare submission packages for Regulatory Authorities and IRB/IEC for completeness and accuracy.
• Ensure required Quality documentation (e.g., QP declaration, GMP Certification) is available for drug release.
• Track and coordinate responses to Regulatory and IRB/IEC queries and deficiency letters with subject matter experts.
• Monitor and report on CTA status updates and study startup progress across assigned projects.
• Maintain internal regulatory files and ensure documentation is complete and accessible.
• Support the review and maintenance of the Trial Master File for regulatory and ethics committee documentation.
• Update global clinical trial registries (e.g., ClinicalTrials.gov) as required.
• Participate in Study Management Team meetings to represent regulatory/study startup perspectives.
• Assist in gathering and sharing regulatory intelligence related to study startup.
• Contribute to the development and maintenance of SOPs and process improvement initiatives.
• Support strategic planning and risk mitigation efforts related to study startup activities.
• Travel up to 10% for team meetings and company events.

Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred.
• 5+ years of experience in clinical trial startup and regulatory affairs within the pharmaceutical or biotech industry.
• Familiarity with CRO operations and global regulatory requirements for clinical trial applications.
• Experience supporting global interventional clinical studies and managing CTA submissions.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Knowledge of GxP, ICH guidelines, and health authority regulations.
• Effective communication and interpersonal skills; ability to work collaboratively across teams.
• Detail-oriented with strong analytical and problem-solving capabilities.
• Proficiency in project management and documentation systems.