Global Regulatory Lead Early Development

My client is considered one of the pioneers in neuroscience. They discover, develop, and deliver worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. This company believes that no other disease area holds as much need or as much promise for break

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Head of Regulatory Affairs

My client is a leading regenerative medicine company focused on the development of biologic and combination product solutions for advanced wound care, surgical, and sports medicine markets.  Originally founded in 1985 as a spin-off of technology developed at MIT in 2017, this company now has approx

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Director Global Regulatory CMC

My client is a global, commercial-stage biotech company with two marketed products and a growing development pipeline of biologic and small molecule programs.  They have retained us to find qualified candidates for a Director Global Regulatory CMC position.  In this role you will be the Regulatory

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Head of Regulatory Affairs

We have been retained to find a Head of Regulatory Affairs 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 regulatory function

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Sr. Manager or Associate Director, Regulatory Project Management

Our client is a clinical-stage biotechnology company focused on transforming the lives of patients through innovative gene therapy programs. They are seeking an Associate Director or Sr. Manager of Regulatory Project Management to serve as the lead project manager for upcoming major marketing applic

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Regulatory & Medical Writing Associate Director

Our client is a clinical-stage biotechnology company focused on transforming the lives of patients through innovative gene therapy programs. They are seeking an Associate Director of Medical & Regulatory Writing to write clinical regulatory documents for submission to the FDA. This is a full tim

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Director Regulatory Affairs

Director Regulatory Affairs My client is a clinical development stage company committed to treating a broad range of diseases.  They have retained us to find candidates for a newly created Regulatory Affairs Director (or Sr. Director) position to develop and drive the Regulatory strategy for th

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Regulatory CMC Associate Director

Our client is a clinical-stage company developing novel cellular immunotherapies based on Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies.  They are seeking an Associate Director of CMC Regulatory Affairs to develop and oversee the execution of CMC regulatory strategies a

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Regulatory Affairs CMC Lead

My client is a leading global biotechnology company focused on serving people with rare disease.  They are seeking a Regulatory Affairs CMC Lead to formulate and implement global CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects

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Regulatory Affairs US Advertising & Promotion Director

My client is a leading global biotechnology company focused on serving people with rare disease.  They are seeking a Regulatory Affairs US Advertising & Promotion Director to serve as an internal expert on FDA regulations, guidance, and enforcement of trends governing the promotion of prescript

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Regulatory Affairs Senior Submissions Specialist/Manager

My client is a leading global biotechnology company focused on serving people with rare disease.  They are seeking a Regulatory Affairs Senior Submissions Specialist to plan, publish (paper, NeES, eCTD), review and deliver regulatory submissions to global health authorities within required timefram

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Global Regulatory Lead

My client is a leading global biotechnology company focused on serving people with rare disease.  They are seeking a Global Regulatory Lead to develop and direct the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological produ

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Regulatory Affairs Labeling Strategy Lead

My client is a leading global biotechnology company focused on serving people with rare disease.  They are seeking a Regulatory Affairs Labeling Strategy Lead to ensure that there is Labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving s

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Regulatory Affairs CMC Strategy Lead

My client is a leading global biotechnology company focused on serving people with rare disease.  They are seeking a Regulatory Affairs CMC Strategy Lead to direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North Ameri

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Regulatory Affairs Associate Director

This commercial-stage biotech company is focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. They are seeking a Regulatory Affairs Associate Director to contribute to regulatory strategies and execution for the company’s collaboration product ca

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Regulatory CMC Associate Director

This clinical-stage biotech company is focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. They are seeking an Associate Director of Regulatory CMC to lead and manage regulatory CMC strategies for biologic programs in development and support post-

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Regulatory Affairs Senior Manager or Manager

This clinical-stage biotech company is developing innovative gene therapy programs for the treatment of rare pediatric diseases.  They are seeking a Regulatory Affairs Senior Manager (or Manager) to contribute to the development and implementation of regulatory strategies and interface with health

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Regulatory Affairs Associate Director

This commercial-stage biotech company is focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. They are seeking a Regulatory Affairs Associate Director (or Sr. Manager) to contribute to regulatory strategies and execution for the company’s early s

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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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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 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 CMC Manager

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 CMC Manager to plan and manage regulatory CMC activities related to life cycle management for their approved product.  Yo

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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 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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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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Global Regulatory Lead

We are seeking a Global Regulatory Lead (Associate Director or Director) to develop global regulatory strategies for early-stage clinical development programs and to lead interactions with major health authorities. This client is a successful global biotechnology company which is developing medicine

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Regulatory Affairs Director/Sr. Director

My client is empowering the fight against cancer by unlocking actionable information from the human genome.  They are seeking a Regulatory Affairs Director or Senior Director to lead global regulatory strategies and execution for their portfolio of novel IVD and companion diagnostic programs. You w

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Regulatory Strategy Sr. Manager or Associate Director

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 Affairs Sr. Manager or Associate Director to contribute to regulatory strategy and lead regulat

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Regulatory Operations Manager or Sr. Manager

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 Operations Manager (or Sr. Manager) to manage and support regulatory systems and lead electroni

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Global Labeling Expert

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 Expert, and in this newly created role you will be responsible for dr

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Global Regulatory Lead 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 7 to 21 people in the past twelve months.  They have partnered with us to fill a newly created Global Regulatory Lead position that has been created th

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Regulatory Advertising & Promotions Director/Senior Director

My client is a global clinical stage biopharmaceutical company founded by pediatricians and entrepreneurs who are dedicated to improving lives of patients with food allergies and other immunological diseases.  They are seeking a Regulatory Advertising and Promotion Director or Sr. Director to lead

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Global Regulatory Labeling Consultant

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 Regulatory Labeling Consultant for a six month, full-time assignment with flex

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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 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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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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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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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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