Head Of Regulatory Affairs

This early-stage biotechnology company is developing a new generation of cell therapies for multiple indications. They are seeking a Head of Regulatory Affairs to develop, plan, and execute regulatory strategies and work closely with global health authorities. In this highly-visible role you will bu

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Regulatory Operations Sr. Specialist

This commercial stage biopharma company was recently honored as one of the best places to work in the Boston area by the Boston Business Journal.  They are seeking a Regulatory Operations Sr. Specialist (or Manager) to lead electronic submissions and coordinate electronic document management for th

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Regulatory CMC Director

Our client is a clinical-stage biotechnology company focused on transforming the lives of patients through innovative gene therapy programs.  They are seeking a Director of Regulatory CMC for biologics who will be responsible for the development and submission of regulatory CMC filings for CAR T c

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Global Regulatory Lead

My client is an established mid-sized global biopharma company with a presence in over 30 countries that has grown their global regulatory team from 7 to 21 people in the last twelve months.  As the Global Regulatory Lead you will be responsible for providing strategic vision and innovative scienti

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Global Regulatory Affairs Director – Oncology

My client is and established global biopharma company that has retained us to find top-tier candidates for a new Global Regulatory Affairs Director (or Sr. Director) role within their science-driven and patient-focused organization. In this newly created position you will be leading US and Global re

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Regulatory Affairs Sr. Director/US Lead

Our client is a successful global biotechnology company which is developing medicines for the treatment of debilitating neurological and neurodegenerative diseases.  They are seeking a Regulatory Affairs Sr. Director/US Lead to develop the US regulatory strategy for products in development and comm

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Regulatory Affairs Manager – Oncology

My client is a clinical-stage biotechnology company focused on transforming the lives of patients with severe genetic and orphan diseases.  They are seeking a Regulatory Affairs Manager to lead the preparation and review of INDs and CTAs and also support major marketing applications for one of thei

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Associate Director, Regulatory Advertising & Promotions

My client is a commercial-stage pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions.   They are seeking a Regulatory Advertising & Promotions Associate Director to join their growing regulatory team and serve as subject matter e

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Regulatory Affairs Director (or Associate Director)

My client is a clinical-stage biotechnology company focused on transforming the lives of patients with severe genetic and orphan diseases.  They are seeking an experienced Regulatory Affairs Director (or Associate Director) to develop and implement regulatory strategies for their Sickle Cell Diseas

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Regulatory Affairs Director

Our client is seeking a Regulatory Affairs Director to oversee all aspects of regulatory affairs for their pipeline of biologic programs while managing a growing regulatory team. This company filed their first marketing application in 2017 and they have a strong pipeline of best-in-class orphan drug

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Labeling Senior Subject Matter Expert – Consultant

My client has engaged us for a newly created Labeling Senior Subject Matter Expert with regulatory expertise in pharmaceutical labeling to review existing processes and documents used to develop, manage and control product labeling. Scope of this role includes pre- and post-approval activities for p

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Head of Regulatory Affairs

We have been retained to find a Head of Regulatory Affairs (Sr. Director) for a clinical-stage biotech company which is unlocking the therapeutic potential of the microbiome through a proprietary drug discovery platform. As the company’s first regulatory hire, you will lead all aspects of the regu

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Manager, Regulatory CMC

This client is an established global specialty biopharmaceutical company focused on treating rare diseases.  They are in search of a Manager, Regulatory CMC to support global regulatory CMC strategies and CMC submissions for multiple biologic programs. You will work closely with colleagues in Regul

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US Regulatory Lead

Our client is a successful global biotechnology company which is developing medicines for the treatment of debilitating neurological and neurodegenerative diseases.  They are seeking a US Regulatory Lead (Associate Director) to develop the US regulatory strategy for products in development and comm

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Global Labeling CCDS Owner

My client is an established mid-size global biopharma company with a presence in over 30 countries that has grown their global regulatory team from seven to 21 people in the past twelve months.  They are seeking a Global Labeling CCDS Owner to drive the development and maintenance of the Company Co

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Regulatory Affairs Senior Manager

This late-stage clinical biotechnology company is focused on the discovery, development, and commercialization of novel treatments for progressive diseases.  They are seeking a Regulatory Affairs Senior Manager to develop US regulatory strategies and execute regulatory activities for their investig

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Manager, Regulatory Operations

My client is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and chronic diseases.  They pride themselves in their family atmosphere where each person's contribution is vital to the company’s overall success.  In this n

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Director, Global Regulatory Affairs

Our client is a commercial-stage, global biopharmaceutical company dedicated to helping individuals with serious and rare diseases.  They are seeking a Regulatory Affairs Director to lead regulatory strategy and implementation for assigned neuroscience programs in development. You will serve as the

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Regulatory CMC Director

Our client is a clinical-stage biotechnology company focused on transforming the lives of patients through innovative gene therapy programs.  They are seeking a Director of Regulatory CMC for biologics who will be responsible for the development and submission of regulatory CMC filings for CAR T c

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Director, Global Regulatory Lead for Early Development

My client is an established mid-size global biopharma company with a presence in over 30 countries that has grown their global regulatory team from seven to 21 people in the past twelve months.  They are seeking a Director, Global Regulatory Lead to provide regulatory leadership for their early sta

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Senior Regulatory and Quality Subject Matter Expert

My client is seeking a Regulatory & Quality Affairs Subject Matter Expert to provide support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC.  In this role, you will serve as regulatory and quality

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Regulatory Labeling Strategy Manager

Our client is a global biopharmaceutical company with multiple approved products available in over 100 countries.  They are seeking a Regulatory Labeling Strategy Manager to support successful development of Company Core Data Sheets (CCDSs) and global labeling.  You will implement regulatory label

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Director, Regulatory CMC

Our client is a growing immuno-oncology company focused on the discovery and development of the next generation of combination treatments in immuno-oncology.  The Regulatory CMC Director will join a motivated and newly formed Regulatory Science & Pharmacovigilance business unit aimed at bringin

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Regulatory Labeling Strategy Team Lead

This client is an established global specialty biopharmaceutical company focused on treating rare diseases, with products available in more than 100 countries. They are seeking a Regulatory Labeling Strategy Team Lead to provide regulatory expertise and guidance to internal stakeholders for successf

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Regulatory Submission Manager

This client is an established global specialty biopharmaceutical company focused on treating rare diseases.  They are seeking a Regulatory Submissions Manager to lead complex submission activity for the company’s innovative portfolio.  You will design and execute global submission plans and prov

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Director, Global Regulatory Lead

This client is an established global specialty biopharmaceutical company focused on treating rare diseases.  They are in search of a Director, Global Regulatory Lead to develop and direct the global regulatory strategy for the development and marketing of drugs and/or biological products across CNS

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Regulatory Strategy Director or Sr. Director

Our client is redefining cancer treatment by developing a broad portfolio of immune-oncology drug candidates.  They are seeking a Regulatory Strategy Director or Sr. Director to join their Regulatory Science team which is aimed at bringing regulatory innovation to drug development and commercializa

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Associate Director, Regulatory Affairs

Our client is a clinical stage pharmaceutical company which is developing novel therapeutics for the treatment of cancer.   They are seeking a Regulatory Affairs Associate Director (or Sr. Manager) to contribute to regulatory strategies and support clinical development activities such as clinical

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Regulatory Strategy Leader

Our client is a commercial-stage biopharmaceutical company focused on the discovery and development of targeted therapeutics for the treatment of rare neuromuscular diseases. They are seeking a Regulatory Strategy Leader to formulate and lead implementation of regulatory strategies for their new gen

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Regulatory Affairs Director

My client is a clinical-stage biotechnology company focused on transforming the lives of patients with severe genetic and orphan diseases.  They are seeking an experienced Regulatory Affairs Director to develop and implement regulatory strategies for their Sickle Cell Disease program from Phase 1 t

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Director Regulatory Affairs

Director Regulatory Affairs My client is a clinical-stage oncology-focused company that is pioneering recombinant antibody mixtures for therapeutic use. We have been retained to fill a newly created Director Regulatory Affairs position that has been created through innovation and growth. In this hi

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