Regulatory Affairs jobs in Wilmington, DE

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DIRECTOR REGULATORY AFFAIRS

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...

CompanyNikang Therapeutics Inc
AddressWilmington, DE
CategoryInformation Technology
Job typeFull-Time
Date Posted 4 weeks ago See detail

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...

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...

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...

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 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...

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...

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...

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...