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1,747 regulatory submissions manager jobs

US - Regulatory Affairs Manager - Perm

Novella Clinical 30 Reviews Pasadena, CA

Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations. · Participate with all disciplines… Novella Clinical

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Senior Documentation Scientist, Regulatory

Genentech 100+ Reviews United States

and Accountabilities: · Manages the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents · Leads… Genentech

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Senior Manager, Regulatory Affairs

Pharmacyclics, Inc. 48 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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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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Regulatory Affairs Specialist

Thermo Fisher Scientific 100+ Reviews Middletown, VA

• Write, prepare, and manage regulatory submissions and filings required for U.S. FDA and… Thermo Fisher Scientific

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Senior Manager, Regulatory Affairs (Hematology/Oncology)

Celgene 94 Reviews Berkeley Heights, NJ

will include, but are not limited to, the following: - Work with Global Regulatory Strategy Leader and/or US Regulatory Strategy Leaders and product… Celgene

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Clinical Research Coordinator

Ochsner 84 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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Associate Director, Statistical Programmer

Sunovion 77 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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CCAR Data Project Manager

Prospect 33 35 Reviews Jersey City, NJ

The main responsibility of this role will be to aid in data governance practices for the work stream. The ideal candidate for this role will have… Prospect 33

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Sr. QC Scientist

Genentech 100+ Reviews United States

Main Purpose of the Position: • Oversee SSFP analytical technology transfer of clinical and commercial portfolio • Apply product development… Genentech

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National Mergers & Acquisitions Tax Manager

PricewaterhouseCoopers 100+ Reviews Washington, DC

- and, prepares for client review submission requests for private letter rulings and technical advice from the IRS.… PricewaterhouseCoopers

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Encounter Data Specialist

Brown & Toland Physicians 44 Reviews San Francisco, CA

• Analyzes and interprets encounter data to identify potential issues and trends. • Coordinates and performs the correction of data… Brown & Toland Physicians

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Senior Clinical Research Associate

Pharmacyclics, Inc. 48 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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Sr. QC Scientist

Roche 100+ Reviews United States

Main Purpose of the Position: • Oversee SSFP analytical technology transfer of clinical and commercial portfolio • Apply product development… Roche

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Post Mark Surveillance Manager- Pharmaceuticals

Fresenius Medical Care - North America 100+ Reviews Waltham, MA

Requires understanding of regulatory obligations for compliance within the scope of the department. Helps provide custo… Fresenius Medical Care - North America

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Regulatory Senior Manager, Immuno Oncology

EMD Serono 53 Reviews Billerica, MA

in preparation and execution of global regulatory strategies Manage the submission and approval… EMD Serono

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Senior Documentation Scientist, Regulatory

Roche 100+ Reviews United States

and Accountabilities: · Manages the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents · Leads… Roche

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Regulatory Engagement Manager

Citizens Financial Group Cranston, RI

The Regulatory Engagement Manager is responsible for the overall effectiveness of the IT Risk & Control Department. The Regulatory Engagement Manager… Citizens Financial Group

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