- Olympus Corporation of the Americas (Center Valley, PA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Regulatory Affairs Operations Manager, is responsible for ... objectives. The Operations Manager will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth and efficient delivery… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required ... + A seasoned, experienced professional with a full understanding of Regulatory Operations ; resolves a wide range of issues in creative ways. +… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... regulatory sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of… more
- Merck (Rahway, NJ)
- …the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations , Process & Systems ... across GRACS. Final External Policy is the official approved version of regulatory requirements or expectations that have undergone a thorough review, consultation,… more
- Amicus Therapeutics (Marlow, OK)
- …and any clinical submission. + Liaison between Manufacturing sites, Global Regulatory Affairs , Technical Operations , Science and Quality Assurance. + ... closely with cross-functional subject matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of regulatory … more
- Danaher Corporation (Raleigh, NC)
- …of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in ... data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team,...data that will resolve or simplifies complexity between commercial, operations , and strategy. + Resilient and comfortable working through… more
- Kelly Services (Sunnyvale, CA)
- …join us as we pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** ... Kelly(R) Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year...for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position offers the… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you...community we serve. Position Summary: Under the leadership of Regulatory Affairs the incumbent manages global… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Merck (Rahway, NJ)
- …a chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing ... + Collect and organize LoQs + Analyze and trend; develop metrics + Regulatory Affairs Detailed Application Verification (DAV)- verification, maintenance + Assist… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Regulatory Affairs Labeling Operations Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US ... opportunity to complete rotations in areas within and beyond Regulatory Affairs . This position will require the...of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …a key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and procedural cross-functional + teams. + ... in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Astrix Technology (Athens, GA)
- Senior Specialist, US Regulatory Affairs Operations Clinical Athens, GA, US Pay Rate Low: 30 | Pay Rate High: 35 + Added - 20/08/2024 Apply for Job Great ... a Part time Sr. Specialist to work for a global , research-driven pharmaceutical focusing on treatment options for diseases...cutting edge treatments and make a difference. **Senior Specialist Regulatory Affairs ** + 20 hours per week… more
- Merck (North Wales, PA)
- …innovative products and services that save and improve lives around the world. The Global Regulatory Affairs and Clinical Safety (GRACS) Quality and ... Compliance (Q&C) team builds trust and confidence with global health authorities by instituting solid & robust processes...& robust processes and systems that adhere to a regulatory quality & compliance framework. The GRACS Quality and… more
- ThermoFisher Scientific (Fremont, CA)
- …regulatory compliance. * Implement policies, procedures, practices and strategies for Regulatory Affairs . * Collaborate with International RA, R&D, Marketing, ... from product inception, launch and throughout the product lifecycle. * Develop global regulatory strategies for medical device products to meet business… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Philips (San Diego, CA)
- …right fit if:** + You have a minimum of 10 years' experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical ... The Director of Regulatory Affairs & Quality will lead...and/or Quality teams. + You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485,… more
- Abbott (Sylmar, CA)
- …with diabetes from routine fingersticks. **The Opportunity** We are currently hiring a ** Regulatory Affairs Operations Specialist I** to work on-site at ... Abbott is a global healthcare leader that helps people live more...additional release authorizations (ARAs) and tender support and overall regulatory operations activities. + Have a full… more