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Available Positions

Principal Consultant, Regulatory

Boston - Remote within U.S. Option Available
As a Principal Consultant, Regulatory, 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.

Principal Consultant, Regulatory – Cell and Gene Therapy

Remote within U.S. Option Available
In this role, you will serve as a regulatory expert in the Regulatory Affairs field for Cell and Gene Therapy client engagements, responsible for leading and/or providing technical consulting for each engagement, while also leading and mentoring a small team of consultants. The successful candidate will have a proven record of regulatory development strategy in regenerative medicines, leadership, and execution within biotech and/or pharmaceutical device companies and will bring exceptional interpersonal communication skills and a flexible approach.

Senior Consultant, GxP Quality

Remote within U.S. Option Available
As a Senior Consultant, Quality, you will be responsible for providing clinical quality assurance expertise to clients in pharmaceutical, biotech, and medical device industries. This role will require you to utilize your background and expertise in GCP, GLP and/or GMP quality management to drive our firm’s strategic quality business and provide consulting expertise to clients.

Senior Consultant, Regulatory CMC

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, Technology Solutions

Boston - Remote within U.S. Option Available
As a Senior Consultant, Technology Solutions you will provide senior-level subject matter expertise and advisement and lead cross-functional project teams through complex engagements focused in the areas of life science technology enablement. You should have a firm understanding of technology solutions used in supporting clinical research, exceptional communication skills, a flexible approach, a positive attitude, and a proven track record in successfully driving and advising the delivery of project-specific outputs through internal and external stakeholders.