- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... up to 10% of the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality,… more
- University of Pennsylvania (Philadelphia, PA)
- …approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager , the Senior Regulatory ... wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Start-Up Specialist Senior-CC Job Profile Title Clinical Research … more
- PCI Pharma Services (Philadelphia, PA)
- …are properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective ... global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving… more
- Actalent (Philadelphia, PA)
- Job Title: Regulatory Affairs SpecialistJob Description We are seeking a full-time Clinical Research & Regulatory Affairs Specialist to work remotely for ... handle regulatory documentation for the NCI, organize and maintain all regulatory affairs documentation/files, resolve regulatory and data queries, and… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies… more
- IQVIA (Wayne, PA)
- ** Manager , Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... practice Principals and other IQVIA teams to strengthen the Manager 's Medical Affairs and consulting expertise. +...life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would… more
- Parexel (Trenton, NJ)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Edwards Lifesciences (Allentown, PA)
- …ground up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior ... Manager , Medical Affairs ) is responsible for providing scientific expertise throughout the development and implementation of clinical studies and clinical… more
- CSL Behring (King Of Prussia, PA)
- Associate Director, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director, Corporate and External Affairs , R&D Portfolio will ... Relationships:** + **Reports to:** Head of Corporate and External Affairs , R&D + **Direct reports to position:** 1 **Main...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… more
- PPL Corporation (Allentown, PA)
- …helping to build and maintain strong, diverse communities today. Overview The Senior Manager Interconnection Affairs is responsible for the daily management of ... and works closely with the Director of Asset Management, Manager of Project Development, Manager of T&D...with Transmission and regulatory group on Federal Regulatory Policy department, State Regulatory /Public affairs… more
- Parexel (Trenton, NJ)
- If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from ... dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …changes). Maintains functional knowledge of relevant safety codes and standards of regulatory bodies including but not limited to The Joint Commission (TJC), ... Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for the Advancement of Medical Instrumentation… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- ThermoFisher Scientific (Allentown, PA)
- …programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs , Clinical, Quality, Pharmacovigilance and Legal teams ... communities depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is highly preferred **Position Summary**… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Senior Manager , External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of ... Medical Affairs external stakeholder engagement activities (including those of the...Compliance and Legal to ensure all engagement strategies meet regulatory and ethical standards. **Cross-Functional Collaboration** + Work close… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Act as key support resource for the Field Medical Affairs team, managing the content repository and version control… more