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289 regulatory submissions manager jobs in Cambridge, MA

Regulatory Submissions Manager - PLS

Shire Pharmaceuticals 100+ Reviews Lexington, MA

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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Principal Regulatory Affairs Associate Devices

Fresenius Medical Care - North America 100+ Reviews 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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Associate Director, Submission Project Management

EMD Serono 53 Reviews 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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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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Pharmacovigilance Submissions Manager

Shire Pharmaceuticals 100+ Reviews Lexington, MA

40% • Monitor ICSR timelines to ensure that submissions to regulatory agencies, business partners, and contract research organizations (CROs) are… Shire Pharmaceuticals

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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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Sr. Submission Specialist (PLS)

Shire Pharmaceuticals 100+ Reviews Lexington, MA

Primarily responsible for the planning and publishing of the GRO-managed submissions portfolio, with accountability of monitoring the submission… Shire Pharmaceuticals

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Sr. Associate Regulatory Affairs

InVentiv Health Clinical 1 Review Cambridge, MA

inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device… StartWire

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Medical Writer / Sr. Medical Writer

Vertex Pharmaceuticals 100+ Reviews Boston, MA

- Collaborate with clinical operations, data management, and other departments on the development and/or revision of protocols, protocol amendments… Vertex Pharmaceuticals

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Drug Safety and Surveillance - Pharmaceuticals

firstPRO 10 Reviews Boston, MA

Post Mark Surveillance - Pharmaceuticals PURPOSE AND SCOPE: Supports my clients mission, vision, core values and customer service philosophy… StartWire

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Senior Manager, Global Regulatory Affairs Project Support

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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Risk Management Lead

Shire Pharmaceuticals 100+ Reviews Lexington, MA

submission to Regulatory Agencies • Manage relationships with and progress… Shire Pharmaceuticals

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Regulatory Affairs Senior Manager, PD-L1

EMD Serono 53 Reviews Billerica, MA

regulatory strategies Manage the submission and approval of applications… EMD Serono

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CMC, Manager Regulatory Affairs

BioStaff Solutions Burlington, MA

This position is responsible for regulatory execution activities associated with investigational and marketed products with a focus on CMC areas. The… Job Board

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