Regulatory Affairs Project Manager

Job Summary

Seeking a full-time Regulatory Affairs Project Manager to work remotely, this role will manage project budgets, timelines, and quality guidelines while ensuring compliance with regulatory requirements and effective communication with team members.

Key responsibilities

• Evaluate the impact of clinical/regulatory changes on projects and business operations
• Manage the preparation of high-quality submissions and responses to regulatory authorities and RFPs/RFIs
• Monitor project schedules and implement risk management activities to ensure deliverables meet expectations

Required qualifications

• University/college degree in life sciences or related field, or equivalent experience
• At least 7 years of experience in the pharmaceutical industry, with 5 years in Regulatory Affairs or Drug Development
• Understanding of governmental regulatory processes and ICH Guidelines
• Working knowledge of project management processes and financial control procedures
• PMP certification or advanced degree is a plus