Senior Manager, Clinical Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Global Clinical Regulatory Leader (Remote).

Key Responsibilities

• Oversees IND submissions and clinical trial applications, ensuring compliance with regulatory requirements
• Collaborates with internal and external stakeholders to facilitate local product registrations and support pharmacovigilance obligations
• Prepares global regulatory strategies and submissions for drugs and gene therapies, including various designations and reports

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 a minimum of 3 years 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 and responding to health agency queries
• Demonstrated ability to build stakeholder relationships with cross-functional teams
• Up to 5% travel required