- ThermoFisher Scientific (Pittsburgh, PA)
- …regulatory direction to product development teams. + Lead all aspects of regulatory compliance of advertising and promotional materials. + Supervise ... cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a...the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development… more
- CSL Behring (King Of Prussia, PA)
- …applicable regulatory systems (eg, Veeva) to ensure tracking and compliance deliverables. + Applies the CSL Leadership Capabilities - Build Bridges, Think ... is preferred. + Minimum of 5 years' experience in the biotech or pharmaceutical industry, with exposure to regulatory activities/submissions and 3 years working… more
- Parexel (Harrisburg, PA)
- …* Work on impactful global programs that directly support patient safety and regulatory compliance . * Collaborate with a diverse, international team across ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs ... He/she will, with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of ... **Job Summary** The Manager , Global Product Quality - Controlled Substances is...and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding… more
- West Pharmaceutical Services (Williamsport, PA)
- …Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, ... Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and… more
- United Therapeutics (Harrisburg, PA)
- …comprehensively support ongoing pricing and contracting operations for all of the Company's pharmaceutical products. The Manager will serve as a key contributor ... are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit… more
- Sumitomo Pharma (Harrisburg, PA)
- …procedures (SOPs) across PV operations and quality systems to ensure consistency, regulatory compliance , and operational excellence. + Support global safety ... inspection preparedness, and cross-functional initiatives to ensure operational excellence and regulatory adherence. The Senior Manager works closely with the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + ... in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role...related Science. + Four years of combined experience in pharmaceutical /medical device industry as a manager in… more
- Sumitomo Pharma (Harrisburg, PA)
- …the protection, preservation, and defensible management of electronic information in compliance with legal, regulatory , and business requirements. **Job Duties ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in...processing of electronically stored information (ESI) for legal and regulatory matters + Coordinate with Legal, Compliance ,… more
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