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Regulatory Affairs Specialist jobs in West Chester, PA

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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 3 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...

3 days ago seen See more...

Associate Director, Regulatory Affairs - Remote OR West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...

3 days ago seen See more...

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...

a week ago seen See more...

Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid)

Teva Pharmaceuticals

West Chester, PA

Influence the strategy and assess the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration.. Ident...

a month ago seen See more...

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...

a month ago seen See more...

Senior Director, Regulatory Affairs II

Teva Pharmaceuticals

West Chester, PA

Manage resources to support submission activities for responsible sites and oversees the coordination and delivery of major submissions to directly support the companies growth strategy. Build relationships with RA staff/authorin...

a month ago seen See more...

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...

a month ago seen See more...

Director Regulatory Affairs

Nikang Therapeutics Inc

Wilmington, DE

Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...

2 weeks ago seen See more...

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...

2 weeks ago seen See more...

Sr. Specialist, Reg Affairs NAM

Iff Family Of Companies

Wilmington, DE

Responsible for overall management of the Protein Solutions product portfolio. Read and interpret US and Canadian regulations; draft submissions/documentation to support product safety for US (e.g., GRAS) and Canada. Serve as the...

3 weeks ago seen See more...

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...

4 weeks ago seen See more...

Lead for Global Regulatory Affairs

Biospace

King Of Prussia, PA

Degree in Biological Sciences or related health sciences. 12+ years experience in the pharmaceutical/health care industry, at least 8 years in Global Regulatory Affairs, Biologics Regulatory experience. 10+ years leadership experi...

a month ago seen See more...

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...

a month ago seen See more...

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