Regulatory Affairs 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 weeks 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 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...

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...

Senior Product Stewardship & Regulatory Affairs Specialist Job

Arkema

United, PA

Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...

OOS Case Manager (US Medical Affairs CAR-T)

Johnson & Johnson

United, PA

Coordinate, supervise and manage all aspects of commercial out-of-specification products life cycle. Lead and partner with multiple internal functions including MSLs, Supply Chain, Safety Management, Quality Assurance, Medical Af...

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...

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...

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...

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...

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...

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...