VP Regulatory Affairs, Biopharma R&D
2 weeks ago
A global pharmaceutical company is seeking a Vice President of Regulatory Affairs for Biopharma R&D. The role involves leading regulatory strategies for product approvals, managing the regulatory affairs team, and ensuring compliance with global regulations. Candidates should have a doctoral degree and extensive experience in the biotech or pharmaceutical industry, including at least 10 years at an executive level. This position is primarily remote with travel requirements.
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Columbia, United States IDEXX Laboratories Full timeHead Of Bioanalytical Scientific Affairs And R&DIDEXX BioAnalytics is experiencing strong growth as a Contract Testing Organization (CTO), supporting over 4,000 research organizations with innovative bioanalytical solutions. The business is positioned to accelerate its regulated service offerings, leveraging organic expansion and targeted M&A to lead as a...
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Columbia Township, United States IDEXX GmbH Full timeIDEXX BioAnalytics is experiencing strong growth as a Contract Testing Organization (CTO), supporting over 4,000 research organizations with innovative bioanalytical solutions. The business is positioned to accelerate its regulated service offerings, leveraging organic expansion and targeted M&A to lead as a trusted scientific partner for biopharma...
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Head of BioAnalytics: Scientific Affairs
1 week ago
Columbia Township, United States IDEXX GmbH Full timeA leading bioanalytical company in Missouri is seeking a Head of BioAnalytics Scientific Affairs and R&D to lead R&D strategy and mentor scientific teams. The ideal candidate will have over 10 years of experience in scientific R&D, a PhD in related fields, and expertise in GLP, GMP, and ISO regulatory standards. This role offers a competitive salary starting...
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Regulatory Affairs Associate
2 weeks ago
Columbia, MD, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. Skills for running review meetings for...
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Regulatory Affairs Associate
7 days ago
Columbia, MD, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. Skills for running review meetings for...
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Regulatory Affairs Associate
2 weeks ago
Columbia, MD, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. Skills for running review meetings for...
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Columbia, United States IQVIA Holdings Full timeDirector, Cardiovascular Regulatory AffairsMCRA an IQVIA business is seeking a Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions for the firm's cardiac interventional clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development...
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Columbia, United States Sumitomo Pharma Full timeA global pharmaceutical company is seeking an experienced Associate Director, Regulatory Affairs focused on oncology in Columbia, SC. This role involves managing regulatory submissions and leading project teams. The ideal candidate will have over 7 years of experience in the biopharmaceutical industry, strong communication skills, and a solid understanding...
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Manager, External Affairs South Carolina
4 weeks ago
Columbia, United States The Nuclear Company Full timeManager, External Affairs South CarolinaThe Nuclear Company is the fastest growing startup in the nuclear and energy space creating a never before seen fleet-scale approach to building nuclear reactors. Through its design-once, build-many approach and coalition building across communities, regulators, and financial stakeholders, The Nuclear Company is...
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Head of Government
3 weeks ago
Columbia, United States Epoch Biodesign Full timeAbout the Role The Nuclear Company is seeking a dynamic and influential External Affairs Manager, South Carolina to lead our engagement and strategic outreach efforts within South Carolina. The External Affairs Manager will be a key driver in shaping the company's reputation, fostering strong relationships with external stakeholders, and navigating the...