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9,471 regulatory submissions manager jobs

CMC Regulatory Submissions Manager

Shire Pharmaceuticals 100+ Reviews Lexington, MA

Primary Duties Under the direction of the line manager, the CMC Regulatory Submissions Manager… of early development programs (IMPD/CTA/IND). The Regulatory Submissions Manager is also responsible… Shire Pharmaceuticals

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Regulatory Submissions Manager - PLS

Shire Pharmaceuticals 100+ Reviews Lexington, MA

and delivery of regulatory submissions. The PLS Manager is also responsible for non-submission regulatory… authorities within required timeframes.  Lead activities for non-submission regulatory reporting on behalf… Shire Pharmaceuticals

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Regulatory Submission Manager - GI/NBU

Shire Pharmaceuticals 100+ Reviews Lexington, MA

quality processes and standards and for ensuring internal compliance for Global Regulatory Affairs (GRA… ). This role collaborates with all functions within GRA to design optimum regulatory standards and interfaces… Shire Pharmaceuticals

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Manager II, Regulatory Affairs

Eastern Virginia Medical School 16 Reviews Norfolk, VA

office. Duties: Conversion of CONRAD’s paper regulatory system to eCTD electronic submission… Gateway, Manage and track regulatory submissions, Perform quality assurance functions for content… Eastern Virginia Medical School

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Specialist II, Regulatory Technical

Sysmex America 20 Reviews Lincolnshire, IL

manager in reviewing device/software related labeling for submissions to the FDA. Other duties… for a Specialist II, Regulatory Technical. The Regulatory Technical Specialist II (RTS) is part of the regulatory Sysmex America

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Regulatory Affairs Manager- Device Change Control

Fresenius Medical Care - North America 100+ Reviews Ogden, UT

-related regulatory submissions as needed. Maintains compliance with US and appropriate international… submissions. Ensures compliance with US (FDA), Canadian, Mexican and other regulatory requirements… Fresenius Medical Care - North America

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Manager, Regulatory Affairs

Fresenius Medical Care - North America 100+ Reviews Austin, TX

-bearing entities. Provides regulatory guidance and support to Fresenius Health Partners’ (FHP… requirements and regulations. Assists the VP of Regulatory Affairs in setting and maintaining the strategic… Fresenius Medical Care - North America

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Quality Assurance/Regulatory Affairs Specialist – easy apply

Alere Accountable Care Solutions 8 Reviews Waltham, MA

. · Domestic and international regulatory submissions and compliance requirements to assure timely release… international submission if applicable (CE) under the guidance of manager and consultant. · Assist… Alere Accountable Care Solutions

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Principal Regulatory Affairs Associate CMC

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

regulatory guidance to manufacturing sites in the preparation and timely submission of required information… to applicable regulatory agencies (primarily US FDA). These submissions may include INDs, NDAs, ANDAs, CBEs, PAS… Fresenius Medical Care - North America

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SENIOR RESEARCH DATA MANAGER

Brigham and Women's Hospital 100+ Reviews Boston, MA

. Participate in cleaning adjudicated data for clinical study reports, interim analyses, regulatory submissions… Job Title: SENIOR RESEARCH DATA MANAGER / 40 HOURS / DAY / BWH - TIMI STUDY GROUP… Brigham and Women's Hospital

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PROJECT MANAGER

Brigham and Women's Hospital 100+ Reviews Boston, MA

, including serious adverse event reporting, and for ensuring all regulatory requirements are met in all… . 8. Identifies, organizes, and ensures accurate completion of required regulatory documents from… Brigham and Women's Hospital

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Senior / Clinical Trial Head – easy apply

Novartis Pharmaceuticals - Oncology East Hanover, NJ

of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission… . * Thorough knowledge of GCPs, clinical trial design, statistics, regulatory processes, and the full life… Novartis Pharmaceuticals - Oncology

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Sr. Manager, Regulatory Affairs

Foundation Medicine 6 Reviews Cambridge, MA

regulatory affairs experience. Experience with FDA submissions is required. Options… Overview: Foundation Medicine is seeking a Regulatory Affairs Sr. Manager. This position… Foundation Medicine

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GRANTS COORDINATOR

Brigham and Women's Hospital 100+ Reviews Boston, MA

of grant, establishment of new funds, monitoring of budgetary performance, and submission of required… . PRINCIPAL DUTIES AND RESPONSIBILITIES: 1. Prepares and assists with grant application submissions Brigham and Women's Hospital

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District Manager

Progress Financial Corporation 10 Reviews Houston, TX

forward, within the boundaries of our regulatory parameters. RESPONSIBILITIES: To be successful… situations that may occur from time to time. This includes taking new loan applications, document submission Progress Financial Corporation

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