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1,275 regulatory submissions manager jobs

Principal Regulatory Affairs Associate Devices

Fresenius Medical Care - North America Waltham, MA

Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all… Fresenius Medical Care - North America

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Senior Manager, Analytical Development

Cameron Craig Group 3 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, Statistical Programmer

Sunovion 71 Reviews New Jersey

Design /develop SAS macros and other utilities to expedite SAS programming activities. Minimum education requirements Masters Experience required… Sunovion

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Senior Clinical Research Associate

Pharmacyclics, Inc. 41 Reviews Sunnyvale, CA

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

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Senior Medical Writer

Seattle Genetics 17 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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Project Management-Manager

Freddie Mac 100+ Reviews McLean, VA

include: • Navigate sponsors of new initiatives/offerings through both Multifamily and Corporate Change Governance (CNBI) processes to ensure all… Freddie Mac

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Regulatory PLS Manager

Shire Pharmaceuticals 100+ Reviews Chesterbrook, PA

65%  Monitor global tracking mechanisms for GRO-managed submissions and ensure GRO delivers high quality, compliant submissions to global health… Shire Pharmaceuticals

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IMPACT System Clinical Project Manager – new

Asen Computer Associates 1 Review Waukegan, IL

Clinical Project Manager-North suburbs of Chgo 6761 47-53.00 an hour w2 contract 6 months+ The Clinical Planning IMPACT Coordinator is responsible… Asen Computer Associates

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Tax Manager, Mergers & Acquisitions

PricewaterhouseCoopers 100+ Reviews San Francisco, CA

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

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Clinical Data Manager – new

Cubist Pharmaceuticals 40 Reviews Lexington, MA

• Contribute to the decision-making process involving data management issues for Phase 1-Phase 4 studies • Work on/lead cross-functional teams and… Cubist Pharmaceuticals

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Associate Director, GLP Toxicology

Seattle Genetics 17 Reviews Bothell, WA

• Manage development toxicology staff and provide oversight for nonclinical toxicology for early research programs and development programs submitted… Seattle Genetics

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Financial Reporting Professionals for XBRL – easy apply

Issuer Direct Corporation 2 Reviews Morrisville, NC

• Plan, schedule, and manage client delivery and production resources • Optimize workflow under deadlines against specific client SLAs… Issuer Direct Corporation

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US - Sr. Clinical Data Management Specialist

Novella Clinical 27 Reviews Waltham, MA

AND DUTIES • Responsible for managing day-to-day activities of data management in a clinical trial • Processes, reviews and organizes patient data and r… Novella Clinical

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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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Endocrinologist--Work for the FDA

Myriddian, LLC White Oak, MD

CDRH is seeking a highly qualified Medical Officer in the field of clinical endocrinology and/or diabetology. Medical Officers are critical to enable… HealtheCareers

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Regulatory Product License Support Lead (Assoc. Director)

Shire Pharmaceuticals 100+ Reviews Chesterbrook, PA

40% of Time Direct GRO-managed Submission Management Activities: • Direct the activity for the GRO-managed submissions portfolio, with first line… Shire Pharmaceuticals

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Director, Regulatory Submissions/Study Start-Up

Medpace 38 Reviews Cincinnati, OH

• Experience managing a group. Travel: 10-20% WHAT TO EXPECT NEXT We look forward to receiving your ap… Medpace

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Manager, Regulatory Affairs, Hematology / Oncology – new

Celgene 91 Reviews Berkeley Heights, NJ

will include, but are not limited to, the following: - Work with Global Regulatory Lead and/or US Regulatory Lead, Regulatory Operations, and… Celgene

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