Senior Manager, Clinical Regulatory Lead

Job Summary

A company is looking for a Senior Manager, Global Clinical Regulatory Lead.

Key Responsibilities

• Collaborates with project teams and stakeholders to ensure effective local product registrations
• Prepares global regulatory strategies and submissions for drugs and gene therapies
• Initiates and executes Clinical Trial Applications (CTAs) in compliance with regulations

Required Qualifications

• Bachelor's degree in a life science field with a minimum of 5 years' experience in the Pharma/Bio Industry, or an MS, PhD, or PharmD with 4-5 years of experience in Regulatory Affairs
• Knowledge of regional regulatory guidelines and the ability to interpret them for assigned projects
• Hands-on experience managing and submitting clinical trial applications
• Demonstrated ability to build stakeholder relationships with cross-functional teams
• Willingness to travel up to 5% as required