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Full-Time Senior Specialist Regulatory Affair jobs in Lexington, MA

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SENIOR MANAGER, REGULATORY AFFAIRS VENDOR GOVERNANCE

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

CompanyBiospace
AddressCalifornia, United States
CategoryInformation Technology
Job typeFull time
Date Posted 3 weeks ago See detail

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

3 weeks ago seen See more...

Sr. Specialist, Regulatory Affairs CMC

Biospace

United States

Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...

4 weeks ago seen See more...

Senior Regulatory Affairs Advisor

Cook Device Solutions

Remote

$100,000 - $125,000 a year

Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...

2 months ago seen See more...

Senior Associate of Regulatory Affairs, CMC

Meitheal Pharmaceuticals Inc

Chicago, IL

Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...

a month ago seen See more...

Regulatory Affairs Specialist

Redbock- An Nes Fircroft Company

Remote

$70.9K - $89.8K a year

Prepare and maintain international submission dossiers. Prepare electronic pre-market and post-market regulatory submissions. Compile Technical Documentations for IVD medical devices. Monitor progress on project deliverables and p...

2 months ago seen See more...

Regulatory Affairs Senior Consultant

Medenvoy Global Bv

Remote

From $100,000 a year

Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...

2 months ago seen See more...

Regulatory Affairs Specialist

Brs

Remote

$62.1K - $78.7K a year

Contractor shall have at least 5 years experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing ones own research proposals and ones own submissions to an IR...

2 months ago seen See more...

Senior Manager, Regulatory Affairs Biocides - Remote

Steris

Alpharetta, GA

Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...

2 months ago seen See more...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

2 months ago seen See more...

Senior Counsel, Regulatory & Legislative Affairs

The Clearing House

Remote

$135K - $171K a year

JD and Licensed attorney, preferably in NY or DC. 5-10 years experience working on payments-related matters in a law firm, bank, or regulatory agency, or on advocacy for the financial industry. Demonstrated ability to quickly gra...

2 months ago seen See more...

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Top Jobs in Lexington, MA

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What are the top cities near Lexington, MA open Full-Time Senior Specialist Regulatory Affair jobs?

There are open Full-Time Senior Specialist Regulatory Affair jobs in several cities including Harrisburg, Lexington, Cincinnati, Austin, New York, Charlotte, Sunnyvale, Lenexa, Secaucus, Bothell, Columbus,

What companies are hiring for Full-Time Senior Specialist Regulatory Affair jobs in Massachusetts?

The top companies hiring now for Full-Time Senior Specialist Regulatory Affair jobs are 3M Health Care Business Group, Care/of, CONVATEC GROUP PLC, Enovis, EPM Scientific, Smith & Nephew,

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