Regulatory Project Manager

Job Summary

A company is looking for an Associate Director/Director, Regulatory Project Management.

Key Responsibilities

• Develop and manage regulatory strategies for global submissions and product approvals
• Oversee the preparation and submission of regulatory filings, ensuring compliance with guidelines
• Collaborate with cross-functional teams to align regulatory activities with project goals and manage timelines

Required Qualifications

• Bachelor's degree in life sciences, pharmacy, or a related field
• Minimum of 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
• Comprehensive understanding of global regulatory requirements and drug development processes
• Strong project management skills with the ability to manage multiple priorities
• Experience in preparing for meetings and interactions with international regulatory agencies