Principal Regulatory Affairs Consultant

Position Overview

As a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. You will serve as a strategic partner, leveraging your expertise to navigate regulatory requirements and optimize pathways for drug submissions.

Work Location

Travel to client sites may be required based on project demands and client expectations.

Key Responsibilities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients.
• Handle FDA Type A, Type B, and Type C meetings.
• Engage in all phases of drug development, from early-stage to post-registration.
• Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams.
• Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality.
• Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines.
• Lead meetings with FDA representatives, prepare briefing documents and responses to agency inquiries.