- Teva Pharmaceuticals (West Chester, PA)
- Director Regulatory Affairs - Submission Management - West Chester, PA Date: Apr 20, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD...Global Regulatory Affairs, with matrixed accountability to Project Management . + Regularly reports to … more
- ManpowerGroup (Lake Bluff, IL)
- …expedite approval of pending registration. + Participates/ Awareness on project plans, regulatory submission strategy, any risks management . + Advises ... interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management , Strategic Area and other… more
- Takeda Pharmaceuticals (Columbus, OH)
- …that will inspire you and empower you to shine? Join us as a Director, Global Regulatory Project Management , GI 2 within our Global Regulatory Affairs ... Therapeutic Area Unit (TAU) + Expertly leads cross functional project submission working groups (SWG) to deliver...continuous improvement of PM tools and processes for Global Regulatory Project Management and Strategic… more
- Liberty Utilities (Massena, NY)
- Project Specialist I, Rates and Regulatory Affairs Massena, NY, US, 13662 **Our purpose is sustaining energy and water for life, and it is demonstrated in ... matters + Provide training on various software/tools in the timely and accurate submission of discovery requests for regulatory proceedings + Assist in updating… more
- Dignity Health (Phoenix, AZ)
- …opportunities? Join the Barrow Neurological Research Team as a Clinical Research Regulatory Project Manager!** **This position will be responsible for steering ... to ICF and protocol development in collaboration with the project management team. Enjoy the flexibility of...the CRO multi-site network. This responsibility includes drafting and submission of regulatory documents and performing quality… more
- UCLA Health (Los Angeles, CA)
- Description The Regulatory Affair Project Manager will oversee, manage and participate in startup research activities as part of the Translational Clinical ... coordination for clinical research studies. This includes responsibility for regulatory coordination of clinical research studies, preparation, submission and… more
- Lilly (Indianapolis, IN)
- …of submissions with the submission specialists, and project management for marketed product support. Responsibilities:: ** Regulatory & Drug Development ... and their expertise with Information Technology tools to develop project management expectations across projects. Based on...Expertise** + Lead CMC submission management process by providing knowledge of CMC … more
- Aston Carter (Thousand Oaks, CA)
- …areas and project teams and departmental governance -Ensure quality of regulatory submission documents at all stages of development -Provide expertise and ... role you will prepare and coordinate the preparation of regulatory submission documents that comply with global...and standards of scientific/technical field - Strong time and project management skills engaging approach and perseverance… more
- UCLA Health (Los Angeles, CA)
- …coordination for clinical research studies. This includesresponsibility for regulatory coordination of clinical research studies,preparation, submission ... Program is seeking an experienced RegulatoryProject Manager to oversee all regulatory aspects of clinical trials, clinical programs,our patient and community… more
- Sanofi Group (Bridgewater, NJ)
- …standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core ... submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation + Ensure that... timelines for clinical trial initiation + Ensure that regulatory messaging for regulatory submission … more
- Sanofi Group (Bridgewater, NJ)
- …standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core ... submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation + Ensure that... timelines for clinical trial initiation + Ensure that regulatory messaging for regulatory submission … more
- Amgen (Washington, DC)
- …world. In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. + ... Table of All Studies, briefing documents, and safety narratives + Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy… more
- Teva Pharmaceuticals (West Chester, PA)
- … Regulatory Operations management team meetings. + Leads major Global Regulatory Affairs project teams. + Develop functional SOPs as well as internal ... support day to day processes ie eCTD submission platforms, integrated data management solutions and submission management and document processing tools.… more
- Abbott (Sylmar, CA)
- …changes. + Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. + Reviews ... Regulatory Affairs Specialist** II at our Cardiac Rhythm Management (CRM) location in Sylmar, CA. As an individual...requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to patients. Responsibilities + **CDx development:** Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan ... for collection, retention, testing and retesting of samples + ** Project Team Participation:** Provide device-specific regulatory insight/guidance during… more
- Boehringer Ingelheim (Ridgefield, CT)
- …+ Oversee the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager. + Support submission rollout for Rest of ... among team members, encourage cross-functional coordination and coordinate with the (senior) regulatory project manager to achieve regulatory milestones &… more
- University of Utah (Salt Lake City, UT)
- …required. + Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project , and other project management tools + SOCRA or ... Until Filled** Yes **Job Summary** Develops and coordinates the submission of regulatory documents for the Population...committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory … more
- Publicis Groupe (New York, NY)
- …with having direct reports + Act as a point of contact for internal Account and Project Management teams to answer submission questions + Level of comfort in ... status meetings + Collaborate with internal, multidisciplinary team members (Account Services, Project Management , Design, User Experience, etc.) + Stay abreast… more
- STERIS (Alpharetta, GA)
- …for regulatory compliance as assigned by upper management . + Provide regulatory guidance and support to project teams and STERIS internal Customers to ... products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department's business partners from the… more
- BeiGene (San Mateo, CA)
- …Head of Global Regulatory Operations, the SD will lead key functions ( Submission Operations Management (SOM), Process and Standards, and Regulatory ... consistent approach. + Lead all operational aspects of global regulatory submission dossier compilation ensuring submission...capable of driving results through hands-on leadership. + Proven project management and time management … more