Regulatory CMC Associate Director

Our client is looking for an Associate Director (or Director) of Regulatory CMC for biologics who will be responsible for the development and submission of regulatory filings for gene therapy projects both in the US and internationally. You will be responsible for driving the development of innovati

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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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Regulatory Affairs Specialist

My client is a global leader in specialty dental devices and equipment.  They are seeking a Regulatory Affairs Specialist to provide regulatory guidance and assistance at all phases of the product lifecycle.  This includes registering products globally, monitoring regulatory compliance, maintainin

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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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Regulatory CMC Associate Director – Biologics

Our client is global specialty biopharma company focused on treating rare diseases and they have multiple approved products.  They are seeking an Associate Director of CMC Regulatory Affairs to serve as the global product leader for CMC regulatory strategy of one or more biologics products. This w

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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 Manager

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

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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Regulatory Affairs Senior Contractor

Our client harnesses the power of T cells to discover life-changing vaccines and immunotherapies. They are seeking a Regulatory Affairs Senior Contractor to develop and lead regulatory strategies for multiple clinical programs.  You will act as liaison between Regulatory Affairs and other functiona

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Regulatory Affairs Contractor

Our client harnesses the power of T cells to discover life-changing vaccines and immunotherapies. They are seeking a Regulatory Affairs Contractor to assist in the preparation and management of regulatory submissions. You will coordinate with external CROs, partners, and consultants in the planning,

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Regulatory Operations Director or Associate Director

This late-stage clinical biotechnology company is focused on the discovery, development, and commercialization of treatments for progressive diseases.  They are seeking a Regulatory Operations Director (or Associate Director) to establish and lead their global Regulatory Operations function and man

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Global Regulatory Liaison

Our client is a clinical-stage biopharmaceutical company focused on developing medicines to transform the lives of people with rare neurological disorders.  They are seeking a Global Regulatory Liaison (Associate Director or Director) to serve as a member of their core development team and be the m

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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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Director/Sr. Director Regulatory Affairs

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

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Regulatory Senior Project Manager

My client is a pioneering gene therapy leader which is transforming the lives of patients suffering from debilitating genetic diseases by developing life-altering treatments. They have partnered with us to find a Regulatory Senior Project Manager to join their science-driven, patient-focused culture

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Regulatory Affairs Global Therapeutic Lead

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 retained us to fill a Global Therapeutic Lead Position that has been created through innovation an

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Regulatory Affairs Director/Sr. Director

Our client is a well-funded biotech company which is developing medicines for multiple therapeutic areas including neurology, dermatology, urology, endocrinology, women’s health, and rare diseases.  They are seeking a Senior Director or Director of Regulatory Affairs to lead the development and e

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Regulatory Operations Senior Manager/Associate Director

Our client is a fast-paced, high-energy biotech company which is expanding their regulatory team.  They are seeking  a Manager of Regulatory Operations to implement regulatory systems, establish processes, and oversee global submissions.  You will work closely with the Regulatory Leads to plan an

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Regulatory Affairs Manager/Sr. Manager

Our client is a fast-paced, high-energy biotech company which is expanding their regulatory team.  They are seeking  a Regulatory Affairs Manager to support global regulatory strategies and manage registrations  for their medical device and drug-device combination products.  You will provide reg

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Global Regulatory Affairs CMC Lead

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.  We are partnering with them to fill a Global Regulatory Affairs CMC Lead Position that has been created thro

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Regulatory Affairs Specialist

My client is a global leader in specialty dental devices and equipment.  They are seeking a Regulatory Affairs Specialist to provide regulatory guidance and assistance at all phases of the product lifecycle.  This includes registering products globally, monitoring regulatory compliance, maintainin

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Senior Global Regulatory Affairs Lead

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.  We have been retained to fill a Senior Global Regulatory Lead Position that has been created through innovat

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Regulatory Affairs Director

Our client is a clinical stage biopharmaceutical company focused on identifying, developing, and commercializing complex biosimilar therapeutics for immunology and oncology indications. They are seeking a Regulatory Affairs Director to lead regulatory strategy and execution of global applications fo

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Regulatory Affairs Manager or Sr. Manager

This is an exciting opportunity for an individual interested in playing a key role in Regulatory Affairs in development programs for personalized medicines.  This individual will develop a broad regulatory experience in both biologics and small molecules drug development, as well as obtain some exp

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Senior Regulatory and Quality Affairs Subject Matter Expert

Development of Medical Countermeasures 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, y

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Senior Regulatory and Quality Affairs Subject Matter Expert

BARDA Antibiotic/Antimicrobial Drug Development 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 thi

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Director/Sr. Director Regulatory Strategy

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 Director or Sr. Director of Regulatory Strategy to formulate and lead implementation of regulatory strateg

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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 Lead

We are seeking a Global Regulatory Lead to develop global regulatory strategies for clinical development programs and to lead interactions with major health authorities.  This client is a successful global biotechnology company which is developing medicines for the treatment of debilitating neurolo

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Regulatory Affairs Director

This client is a clinical stage biotechnology company developing gene therapies for the treatment of rare neurodegenerative disorders.  They are seeking a Director of Regulatory Affairs to lead strategies and activities for their pipeline programs and manage upcoming US and EU submissions.  You wi

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Regulatory Affairs Labeling & Promotion Senior Consultant

My client is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver disease.  They have partnered with us to fill a newly created long term Sr. Regulatory Consulting Labeling & Promotion position.  In this role, you would be wo

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