Regulatory Manager jobs in Pennsylvania

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MANAGER, CMC REGULATORY AFFAIRS - REMOTE OR WEST CHESTER, PA

Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...

CompanyTeva Pharmaceuticals
AddressWest Chester, PA
CategoryInformation Technology
Date Posted 4 days ago See detail

Manager, CMC Regulatory Affairs - Remote OR West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...

Director Regulatory Affairs - Submission Management - West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Responsible to manage Product Submission Team and dossier timelines. Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management. Regularly reports to management on progr...

Senior Associate, Regulatory Oversight Management

Bny Mellon

Pittsburgh, PA

Communicates with internal and external parties as needed and makes recommendations on necessary procedural/control changes on Regulatory Oversight Management matters. Gathers data and prepares materials for more senior team membe...

Senior Manager Regional Regulatory Affairs

Biospace

King Of Prussia, PA

You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...

Associate/Manager – CMC Regulatory

Biospace

Sylvania, PA

Responsible for the generation and execution of country specific CMC regulatory strategies. Author and review global CMC dossiers. Coordinate and contribute to responses to regulatory agency questions. Participate as an active mem...

Manager, Regulatory Affairs

Biospace

King Of Prussia, PA

You will plan, direct, and monitor Regulatory Affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce, sell, and distribute its...

Manager, CMC Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

West Chester,

Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...

Group Manager, Regulatory Affairs

Globus Medical, Inc.

Audubon, PA

$110K - $139K a year

Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval...

Manager, Regulatory Affairs - Biosimilars

Teva Pharmaceuticals

West Chester, PA

The Manager is responsible for supporting the Regulatory Affairs strategic vision and regulatory leadership in defining the global regulatory strategy for biosimilar projects. The Manager is accountable to support the Global Regul...