Regulatory Operations jobs

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ASSOCIATE DIRECTOR, GLOBAL DELIVERY MANAGER-REGULATORY OPERATIONS

Lead delivery of global submissions including oversight of coordination of US, EU, and BIR deliverables with vendor and US, EU, and BIR strategic plan. Create global submission dossier and ensure consistency and quality of submiss...

CompanyBiogen
AddressRemote
CategoryInformation Technology
Salary$135,000 - $235,000 a year
Date Posted 2 weeks ago See detail

Associate Director, Global Delivery Manager-Regulatory Operations

Biogen

Remote

$135,000 - $235,000 a year

Lead delivery of global submissions including oversight of coordination of US, EU, and BIR deliverables with vendor and US, EU, and BIR strategic plan. Create global submission dossier and ensure consistency and quality of submiss...

Part-Time Contractor, Regulatory Operations

Summit Therapeutics Sub, Inc.

Menlo Park, CA

$50 - $60 an hour

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine k...

Manager Regulatory Operations

Biospace

Bridgewater, NJ

Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications. Responsible for the archival of submission and submission related documents in the EDMS. Contribute to...

Associate Director, Regulatory Operations

Biospace

Waltham, MA

Serve as an administrator for RIM and provide direct support to functional disciplines and program teams responsible for developing submission contents. Manage day-to-day submission activities both internally and in collaboration...

Utilization Management Manager Regulatory Operations

Oscar Health

Tempe, AZ

$97,200 - $127,575 a year

Be the example of the continuous improvement mindset, providing direction and influence, while demonstrating actual results of organizational behavior change in this area. Demonstrate the proper approach with implementation of Con...

Manager - Quality & Regulatory Operations

Amerisourcebergen Corporation

Edwardsville, KS

Responsible for the maintenance, execution, and monitoring of the BU Location's Quality Management System (QMS), Good Distribution Practices (GDP), and compliance with all local state (BOP, DOH, etc.),, and federal regulations (DE...

Staff/Principal Regulatory Affairs Specialist (Operations)

Recor Medical

Palo Alto, CA

Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Rep...

Financial and Regulatory Reporting - TSR Operations, Senior Associate

State Street

Quincy, MA

Not disclosed

Manage the Regulatory Reporting production process, calendar and relationship for various clients and ensure that all production schedules (including those with the off-shore teams) are completed in a timely manner so that all tea...