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1,662 regulatory submissions manager jobs

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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Senior Manager, Regulatory Affairs

Pharmacyclics, Inc. 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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Sr. Manager Regulatory Affairs

Thermo Fisher Scientific 100+ Reviews Frederick, MD

• Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, address… Thermo Fisher Scientific

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US - Regulatory Affairs Specialist - Perm

Novella Clinical 30 Reviews Research Triangle Park, NC

· Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing… Novella Clinical

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Tax Mergers & Acquisitions Manager

PricewaterhouseCoopers 100+ Reviews Dallas, TX

- 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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Financial Project Manager/PMO

Prospect 33 35 Reviews Jersey City, NJ

that such a role entails, as well as several years experience within investment banking… Prospect 33

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Regulatory Specialist III

HeartFlow 18 Reviews Redwood City, CA

/ submissionsManage completion of regulatory requirements for market… StartWire

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Data QC Scientist/Manager

23andMe 13 Reviews Mountain View, CA

managing experiments for regulatory submission. What youll do • Day… 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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Manager, Regulatory Affairs, Latin America – new

Celgene 94 Reviews Summit, NJ

will include, but are not limited to, the following: 1. Work with Global & Regional Regulatory Strategy Leader and Functional teams to implement… Celgene

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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… Pharmacyclics, Inc.

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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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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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Senior Regulatory and Product Compliance Specialist Fairlawn NJ

Thermo Fisher Scientific 100+ Reviews Fair Lawn, NJ

for MHRA, TGA, SFDA. Provide International (outside North America) regulatory submission support. Coordinate with International regulators on… Thermo Fisher Scientific

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Manager / Senior Manager Regulatory Affairs

Atara Biotherapeutics Thousand Oaks, CA

• Manage assigned regulatory projects and closely collaborate with Clinical, Regulatory Operations, other scientific and technical departments and… StartWire

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Surveillance Scientist

The Medicines Company 16 Reviews Parsippany, NJ

• Support operational and process improvement activities within GPV, e.g. data handling conventions, signal detection and management, safety… The Medicines Company

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Mergers and Acquisitions Tax Manager

PricewaterhouseCoopers 100+ Reviews San Jose, 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 Research Coordinator

Ochsner 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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Senior Medical Writer

Seattle Genetics 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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