Regulatory Affairs Senior Manager

This company is a global leader in advanced molecular testing solutions. They are seeking a Regulatory Affairs Senior Manager who can develop and manage global regulatory strategies and filings for a portfolio of IVD products.  You will lead the preparation and submission of regulatory applications

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Regulatory Affairs Manager

This company is a global leader in advanced molecular testing solutions. They are seeking a Regulatory Affairs Manager who can lead commercial regulatory activities for approved IVD products.  This includes promotional review, labeling, and other regulatory filings. You will work closely with Marke

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Regulatory Affairs Manager

This innovative diagnostics company develops automated IVD solutions for molecular testing. They are seeking a Regulatory Affairs Manager who can develop regulatory strategies and provide regulatory guidance for a portfolio of IVD products.  You will lead the preparation and submission of regulator

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Regulatory Affairs Specialist

This innovative diagnostics company develops automated IVD solutions for molecular testing. They are seeking a Regulatory Affairs Specialist to coordinate regulatory submissions with the FDA and EU for their IVD products. You will maintain technical files and regulatory documentation and support pro

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Regulatory Affairs Senior Specialist

This innovative diagnostics company develops automated IVD solutions for molecular testing. They are seeking a Regulatory Affairs Senior Specialist to work on regulatory submissions with the FDA and EU for their IVD products. You will reviewing technical reports, labeling and advertising material fo

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Regulatory Affairs Senior Director

This San Diego biopharma company specializes in identifying, developing and delivering life-changing therapies to people living with rare disease. They are seeking a Regulatory Affairs Senior Director who can develop and lead global regulatory strategies for approved products and programs in develop

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Regulatory CMC Director

This San Diego biopharma company specializes in identifying, developing and delivering life-changing therapies to people living with rare disease. They are seeking a Regulatory CMC Director to lead their CMC Regulatory function globally and manage one direct report.  You will develop global CMC str

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Regulatory Affairs Manager

This small, clinical stage pharmaceutical company is developing life-changing therapies for genetic diseases.  With their lead candidate for DMD in Phase 3, they are seeking a Regulatory Affairs Manager to join their growing team.  You will contribute to and execute upon global regulatory strategi

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Regulatory Affairs Manager

This client develops, manufactures, and markets a broad range of innovative diagnostic products. They are seeking a Regulatory Affairs Manager who can manage a small team of Regulatory professionals and oversee regulatory submissions for pre-market IVD products. You will work closely with cross-func

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Regulatory CMC Director – Remote

This San Diego biotechnology company is focused on novel biological and drug delivery technologies.  They are seeking a Regulatory CMC Director that can develop and execute on regulatory CMC strategies for assigned partner programs, and manage junior-level staff. You will work closely with cross-fu

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Regulatory Affairs Director

This small but growing Bay Area pharmaceutical company has one approved product and a very strong pipeline of novel therapeutics for the treatment of rare diseases.  They are seeking a Regulatory Affairs Director or Associate Director that can contribute to and execute on regulatory strategies for

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Regulatory CMC Manager Contractor – REMOTE

This biotechnology company is focused on novel biological and drug delivery technologies.  The Regulatory Affairs CMC contractor will provide support in the development and implementation of global regulatory CMC strategies for marketed and development products. This individual will lead or support

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Clinical Regulatory Affairs Director

This Bay Area pharmaceutical company is developing and commercializing innovative therapies for women's health and prostate cancer.  With the anticipated FDA approval of two NDAs this year, they are growing rapidly and expanding their team.  They are seeking a Clinical Regulatory Affairs Director

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Commercial Regulatory Associate Director or Director

This Bay Area pharmaceutical company is developing and commercializing innovative therapies for women's health and prostate cancer.  With the anticipated FDA approval of two NDAs this year, they are seeking an Associate Director or Director of Commercial Regulatory Affairs who can review and approv

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Regulatory CMC Director

This San Diego biotechnology company is focused on novel biological and drug delivery technologies.  They are seeking a Regulatory CMC Director that can develop and execute on regulatory CMC strategies for assigned partner programs, and manage junior-level staff. You will work closely with cross-fu

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Regulatory CMC Manager

This client is one of the largest contract manufacturers of biologics in the world.  Due to a significant expansion at their Portsmouth site, they are seeking a Regulatory CMC Manager (or Sr. Associate) to provide regulatory support for multiple client projects.  In this role you will contribute t

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Senior Director, Regulatory Team Leader

This global pharmaceutical company is seeking a Senior Director, Regulatory Team Leader to oversee its Rare Disease portfolio.  In this role you will provide strategic input into US and global regulatory strategies, while leading a team of direct reports.  You will also serve as the primary contac

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Regulatory CMC Director or Associate Director

This clinical-stage immune-oncology company is developing gene and cell therapies for the treatment of blood cancers and solid tumors.  They are seeking a Director (or Associate Director) of Regulatory CMC  to develop and execute on regulatory CMC strategies for their pipeline of novel biologic pr

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Regulatory Affairs Senior Director

This clinical-stage oncology company is developing the next generation of treatments for various types of cancers.  They are seeking a Senior Director of Regulatory Affairs to develop and execute on regulatory strategies for their pipeline of novel programs. As their first regulatory hire, you will

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