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Available Positions

Lead Consultant, Regulatory Affairs

Boston - Remote within U.S. Option Available
As a Lead Consultant, you will manage multiple Regulatory programs for development stage biotech, pharmaceutical, and device companies to guide, develop, and advise on regulatory development strategies and submissions. You will support and guide clients on activities spanning from pre-IND through market approval and ensure consistent high-quality client deliverables.

Senior Consultant, Regulatory CMC (Biologics)

Remote within U.S. Option Available
As a Senior Consultant, Regulatory CMC, you will be responsible for managing multiple regulatory programs for emerging biotechnology and pharmaceutical companies, independently developing regulatory strategies, and leading the preparation, authoring, and review of regulatory submissions. Additionally, you will take a leadership role in interacting with the FDA, interact with potential clients in a business development role, and ensure consistent high-quality delivery of client deliverables and goals.

Senior Consultant, Regulatory CMC (Small Molecules)

Remote within U.S. Option Available
As a Senior Consultant, Regulatory CMC, you will be responsible for managing multiple regulatory programs for emerging biotechnology and pharmaceutical companies, independently developing regulatory strategies, and leading the preparation, authoring, and review of regulatory submissions. Additionally, you will take a leadership role in interacting with the FDA, interact with potential clients in a business development role, and ensure consistent high-quality delivery of client deliverables and goals.