- Teva Pharmaceuticals (West Chester, PA)
- Director Regulatory Affairs - Submission Management - West Chester, PA Date: Apr 20, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: Apr 20, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II will...how systems are integrated to support day to day regulatory and submission publishing business processes with… more
- Catalent Pharma Solutions (Philadelphia, PA)
- **Associate Director , Regulatory Affairs ** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... and Catalent employee. The primary duty of the **Associate Director , Regulatory Affairs ** is to...experience and sound knowledge of GMP regulations and multi-national regulatory submission requirements + Must demonstrate organizational… more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs , Strategy - Innovative Medicine (West Chester, PA or Remote) Date: Apr 29, 2024 Location: West Chester, United States, ... people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs , is...regulatory knowledge of IND and NDA/BLA content and submission experience. Working within Teva Innovative Medicines, this role… more
- Merck (Philadelphia, PA)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. +… more
- Canon USA & Affiliates (Trenton, NJ)
- …req1193** **OVERVIEW** Responsible for pre-market and post-market activities as assigned by the Director , Regulatory Affairs to include new product planning ... regarding regulatory issues as assigned by the Director , Regulatory Affairs . + Provide...CMSC Business Unit Managers and Engineering Managers in FDA regulatory submission preparation. + Support activities related… more
- University of Pennsylvania (Philadelphia, PA)
- …accreditation implications. Supports special projects determined by the Associate Dean for Academic Affairs and Director of Regulatory and Master of ... submission and follow up with all reports or regulatory /compliance needs. + Supports daily regulatory /accreditation operations....duties as determined by the Associate Dean for Academic Affairs and the Director of Regulatory… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Director , GRO Regulatory Project Management and be a part of the Global Regulatory Affairs Team. **How you will contribute:** + As Associate Director , ... process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project… more
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located in ... authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on...laws (with a focus on FDA), regulations, guidances and regulatory submission routes available for new study… more
- Cardinal Health (Trenton, NJ)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory ...+ Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + Submission … more
- Takeda Pharmaceuticals (Exton, PA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... US Medical team, you will report to the Associate Director , Ad/Promo Regulatory Review. You will be... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Teva Pharmaceuticals (West Chester, PA)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the… more
- University of Pennsylvania (Philadelphia, PA)
- …with community partners, making scientific presentations, and creating manuscripts for submission to peer-reviewed journals. The Director is a member ... wellness programs and resources, and much more. Posted Job Title Research Project Director Job Profile Title Manager Research Project C Job Description Summary The… more
- Universal Health Services (King Of Prussia, PA)
- …Nursing, Admissions, Business Development, Process Improvement, Finance, Clinical Services, and Regulatory Affairs that effectively drive patient care outcomes. ... 24 bed expansion planned for 2026. UHS is currently recruiting for the Executive Director for expanded inpatient program at Altru Health System in Grand Forks, ND.… more
- Merck (Trenton, NJ)
- …diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation. **Educational Qualifications:** + ... there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a highly matrix-based organization. There… more
- Merck (North Wales, PA)
- …Pipeline Advertisement._** Under the guidance of a senior leader, a Director , Outcomes Research has primary responsibility for developing value evidence strategies, ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
- Merck (North Wales, PA)
- …Advertisement._** Under the guidance of a senior leader, an Associate Director Outcomes Research has primary responsibility for planning/managing real world and ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- University of Pennsylvania (Philadelphia, PA)
- …departments and outside parties. The Manager position will report directly to the Director of Research Operations for Dermatology. The Manager will work closely with ... the Director in overseeing aspects of dermatological disorders clinical research...operations of the clinical trials, including study enrollment, adherence, regulatory compliance, timely completion of project milestones, supervision of… more
- University of Pennsylvania (Philadelphia, PA)
- …of Dermatology. This role will be responsible for the preparation, review, and submission of sponsored program proposals for submission to sponsors. This ... award duties include award set up and management for financial and regulatory compliance, meeting regularly with investigators for expense reporting and projects,… more
- University of Pennsylvania (Philadelphia, PA)
- …with grant proposal preparation, creating grant templates and other related documents including submission of grants via ASSIST, PennERA & other grant submission ... these grants. + Review granting agency regulations, inform investigators of regulatory requirements and ensure compliance. + Prepare & maintain confidential… more