Senior Regulatory Strategist

Job Summary

A company is looking for a Senior Regulatory Strategist to provide global strategic regulatory guidance and oversight for clients' pharmaceutical, biologic, and medical device development programs.

Key Responsibilities:

• Serve as the senior regulatory expert, providing strategic advice on product development and regulatory submissions
• Develop and implement comprehensive global regulatory strategies for drug, biologic, and device programs
• Oversee the preparation, submission, and maintenance of global regulatory filings, ensuring compliance with regulations

Required Qualifications:

• PhD/PharmD (or equivalent) with 20 years of experience in regulatory affairs and global regulatory strategy
• Deep knowledge of global regulatory frameworks and experience with FDA, EMA, and Health Canada
• Demonstrated ability to mentor and train regulatory professionals
• Regulatory Affairs Certification (RAC) desired
• Experience with complex product development and direct agency interaction