- J&J Family of Companies (Spring House, PA)
- Expert RA Professional Submissions , Submission Management - 2406217374W **Description** Johnson & Johnson Innovative Medicine is recruiting for Expert ... potential. At Johnson & Johnson, we all belong. The Expert RA Professional Submissions...Creates and manages the Dossier Plan(s)/Submission Packages for HA Submissions in line with clinical trials regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory...Expert Group (REG), as appropriate. + Ensure US RA contributions to all local and global project related… more
- Unilever (San Francisco, CA)
- THE ROLE: REGULATORY AFFAIRS MANAGER You are a compliance expert with roots in the supplement industry and have a passion for supporting the innovation of ... RA Manager will serve as the company's operational expert on claims substantiation, providing direction and insights to...to the business. + Manage and track all regulatory submissions , including FDA 30-day notices for… more
- University of Pennsylvania (Philadelphia, PA)
- …needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, ... needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA,… more
- Kelly Services (Franklinton, NC)
- … Manager!** **About the Team** Our client's Regulatory Team seeks an experienced Regulatory Affairs professional to join the US team, focusing on ... **Kelly(R) Science & Clinical is seeking** **a Regulatory Affairs Manager** **for a position...regulatory documents, and lead submission meetings. + Oversee regulatory submissions to agencies and ensure timely… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - Digital Health Technology** will work on-site ... way people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - Digital Health Technology** will provide support for… more
- Dartmouth Health (Lebanon, NH)
- …to CTSA operations. Responsibilities * Serves as the internal subject matter expert on quality and safety matters related to SYNERGY-supported research. * Performs ... quality reviews of CTSA-related submissions to NIH’s National Center...experience supporting clinical trial initiation and conduct, and related regulatory work, or the equivalent in education and experience.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/ RA ) ... geographic locations you would consider. * Olympus is looking for Global MDR Submissions Analyst II. Hiring Location: US **Job Description** Global MDR Analyst II is… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during ... to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report...you will contribute:** + Independently plan, execute and manage regulatory submissions for assigned compounds in various… more
- University of Pennsylvania (Philadelphia, PA)
- …trials that offer cutting-edge oncology treatments. Contingent upon funding. The CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs ... regulatory start-up approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the … more
- University of Washington (Seattle, WA)
- …work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory ... position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase... regulatory coordinator is responsible for overseeing the regulatory affairs of the UW Hematologic Malignancies… more
- Takeda Pharmaceuticals (Columbus, OH)
- …is highly preferred + Advanced education or credentialing in regulatory affairs and project management preferred Demonstrated expert experience leading high ... and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners..., to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory… more
- Interior, US Fish and Wildlife Service (Hadley, MA)
- …Financial and Business Management System (FBMS). Serves as a FBMS reports expert user for within the assigned areas of responsibility. Completes certification of ... (3) track, analyze and brief management on data analysis; (4) Analyzing budget submissions from a program or component for compliance with agency policy; (5)… more
- Interior, US Fish and Wildlife Service (Hadley, MA)
- …Financial and Business Management System (FBMS). Serves as a FBMS reports expert user for within the assigned areas of responsibility. Completes certification of ... (3) track, analyze and brief management on data analysis; (4) Analyzing budget submissions from a program or component for compliance with agency policy; (5)… more
- Takeda Pharmaceuticals (Boston, MA)
- …and/or related experience. + Experience in reviewing, authoring, or managing components of regulatory submissions . + Expert knowledge of drug development ... regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …generated and communicated outside the organization for the purposes of regulatory submissions , publication, podium presentations, and marketing communications, ... timelines and project plans related to clinical science deliverables. + Partner with Regulatory Affairs , Clinical Research, and Medical Affairs leadership in… more
- Houston Methodist (Houston, TX)
- …research program experience **LICENSES AND CERTIFICATIONS - REQUIRED** + RAC - Regulatory Affairs Certifications (RAPS) **OR** + CCRC - Certified Clinical ... Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific...Communications Group Lead, Solid Tumors. As a subject matter expert on scientific publications best practices and the development… more
- Takeda Pharmaceuticals (Boston, MA)
- …line management + Supports and/ or leads assigned device-related aspects of global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, ... and implementation of innovative pure device and combination product regulatory strategies particularly pertaining to the development, registration, commercialization… more
- ManpowerGroup (Alameda, CA)
- …$50-$55/hr on W2** **Education:** Bachelor's degree **Experience Background (Any):** APAC regulatory submissions in Medical Devices or Pharmaceutical industries. ... client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal...13485 and IEC 60601. + Knowledge of interactions between RA and other departments to pre/post-market RA … more