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1,863 regulatory submissions manager jobs

Associate Director, Submission Project Management

EMD Serono Rockland, MA

•Responsible and accountable for planning, managing, tracking and on-time production of regulatory deliverables for major global submissions… EMD Serono

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CCAR Regulatory Reporting Project Manager

Prospect 33 35 Reviews Little America, NY

The bank is currently upgrading Regulatory data sourcing for reporting to lead changes in formulating the CCAR initiatives for Federal Mandates. They… Prospect 33

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Program Director - Commercial Regulatory Affairs

Genentech 100+ Reviews United States

CORA (Commercial Regulatory Affairs) is part of the broader Product Development Regulatory Affairs (PDR) organization that interprets the needs of… Genentech

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Program Director - Commercial Regulatory Affairs

Roche 100+ Reviews United States

CORA (Commercial Regulatory Affairs) is part of the broader Product Development Regulatory Affairs (PDR) organization that interprets the needs of… Roche

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Sr. Manager Regulatory Affairs

Life Technologies 100+ Reviews Frederick, MD

• Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, address… Life Technologies

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Alliance Manager -- Analytical Development

Cameron Craig Group 2 Reviews Boulder, CO

• Assist in preparing and reviewing relevant CMC sections in support of regulatory submissions. • Provide significant input to departmental strategies, polic… Cameron Craig Group

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Senior Manager, Regulatory Affairs

Pharmacyclics, Inc. 49 Reviews Sunnyvale, CA

• Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs… Pharmacyclics, Inc.

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Director, Bioanalytical CRO Management

Vertex Pharmaceuticals 100+ Reviews Boston, MA

The position is responsible for CRO Bioanalytical project oversight, ensuring data integrity and regulatory compliance of all bioanalytical data in… Vertex Pharmaceuticals

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CCAR Operational Risk Senior Project Manager

Prospect 33 35 Reviews Little America, NY

that such a role entails. CCAR experience is a big plus. Naturally, all candidates will will be highly proficient in Microsoft Excel, Visio and… Prospect 33

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Clinical Research Coordinator

Ochsner 92 Reviews New Orleans, LA

• Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the… Ochsner

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Senior Medical Writer

Seattle Genetics 18 Reviews Bothell, WA

• Write and edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents… Seattle Genetics

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Associate Director, Statistical Programmer

Sunovion 80 Reviews New Jersey

include group leadership, process development (programming library, guidelines, standard operating procedures) and project team leadership of outside… Sunovion

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Regulatory Technologies & IM Manager

Shire Pharmaceuticals 100+ Reviews Lexington, MA

, standards, and procedures for regulatory submissions. • Manages and supports tools… Shire Pharmaceuticals

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US - Regulatory Affairs Specialist - Perm

Novella Clinical 31 Reviews Research Triangle Park, NC

· Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing… Novella Clinical

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Senior Clinical Research Associate

Pharmacyclics, Inc. 49 Reviews Sunnyvale, CA

• Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements • Develop clinical trial protocol synopsis… Pharmacyclics, Inc.

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Manager, Medical Writing / Senior Manager, Medical Writing

ARIAD Pharmaceuticals, Inc 8 Reviews Cambridge, MA

• Plan, prepare, write, review, edit, format, and finalize clinical and regulatory documents for ARIAD’s proprietary compounds. Documents will… ARIAD Pharmaceuticals, Inc

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Associate Program Director - Commercial Regulatory Affairs

Genentech 100+ Reviews United States

CORA (Commercial Regulatory Affairs) is part of the broader Product Development Regulatory Affairs (PDR) organization that interprets the needs of… Genentech

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