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Available Positions

Associate Principal Consultant, GxP Quality

Boston
As an Associate Principal Consultant, GxP Quality, you will be responsible for leading the development quality consulting business to ensure successful engagement, scoping, execution and delivery of client work. You will provide creative and strategic quality and compliance approaches to meet the unique needs of each client, acting as head of quality for the development-stage business, and leading and managing quality team members.

Consultant, Project Associate (Regulatory Affairs)

Boston
As a Consultant, Project Associate, you will be responsible for establishing project timelines, providing specific subject matter experts support for specific projects, and identify opportunities for project expansion and assist with devising support strategy.

Principal Consultant, Regulatory

Remote within U.S. Option Available
In this role, you will serve as a regulatory expert in either the areas of Regulatory Development or Regulatory CMC to our clients and will be responsible for leading and/or providing technical consulting for our development stage engagements, while also leading and mentoring a small team of consultants. The successful candidate will have a proven record of regulatory development strategy, leadership, and execution within biotech, pharmaceutical and/or device companies and will bring exceptional interpersonal communication skills and a flexible approach.

Senior Consultant, Regulatory Affairs

Remote within U.S. Option Available
As a Senior Consultant, Regulatory Affairs, 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 and other health authorities, interact with potential clients in a business development role, and ensure consistent high-quality delivery of client deliverables and goals.

Senior Consultant, Regulatory Operations

Boston - Remote within U.S. Option Available
As a Senior Consultant, Regulatory Operations, you will be responsible for managing multiple regulatory programs for emerging biotechnology and pharmaceutical companies, overseeing the submission of regulatory documents to the FDA, providing guidance on eCTD publishing standards, and developing reference guides and tools for regulatory submissions. Additionally, you will assess current Halloran systems and take a leadership role in proposing and implementing new aspects for regulatory processes, coordinate electronic signature systems, and provide regulatory operations training to new hires, Halloran teams, and client teams.