- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- Overview We are hiring a Clinical Affairs Program Manager. The Clinical Affairs Program Manager will be responsible for the development and generation of ... medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Program Manager will perform annual activities associated with Post Market… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …years of experience in Technical Support or Customer Service and/or Quality Assurance/ Regulatory Affairs /Compliance, technical and customer support in a medical ... has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a… more
- CSL Behring (King Of Prussia, PA)
- …serious and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our King of ... will contribute to the vision, goals and improvement of Global Regulatory Affairs and includes...to enable a and planning to future our requirements. Lead regulatory strategies and activities globally -… more
- Sanofi Group (Cambridge, MA)
- ** Global Regulatory Affairs Lead (GRL)** **Mission statements** + The Global Regulatory Affairs Lead (GRL) is the fully accountable ... of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global ), in early… more
- Teva Pharmaceuticals (West Chester, PA)
- …timelines. + Accountable to Global Regulatory Lead and Global Regulatory Affairs , with matrixed accountability to Project Management. + Regularly ... Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be...adaptations needed as challenges arise. + In collaboration with regulatory lead and project leader, conduct scenario… more
- BeiGene (San Mateo, CA)
- …industry best practice submission processes. The SD will successfully lead the Global Regulatory Affairs organization in identifying and guiding process ... and values. As the Head of Global Regulatory Operations, the SD will lead key...degree preferred. + Required Experience: Minimum of 12 years Regulatory Affairs and/or Regulatory Operations… more
- Teva Pharmaceuticals (West Chester, PA)
- …biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure ... will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in...applications and product life cycle management submissions with the Global Regulatory Affairs Team from… more
- Sanofi Group (Cambridge, MA)
- We are currently seeking a Global Regulatory Affairs Lead (GRL) who will be the fully accountable decision maker for the development & execution of ... of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global ), in… more
- Amgen (Washington, DC)
- … Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is: + To lead GRTs within Amgen's GRAAS organization + To ... Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides...you will lead one or more the Global Regulatory Teams (GRT) in the … more
- System One (Deland, FL)
- Position: CONTRACTOR -- Director, US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local ... 95/hr Purpose and Scope of Position The Director, US Regulatory Affairs & Global Development...product success. + Exhibit strong leadership skills to effectively lead and manage a regulatory affairs… more
- Randstad US (Chicago, IL)
- global regulatory affairs strategist. +...for assigned due diligences, under the direction of the Global Regulatory Strategy Lead (GRSL). An ... be responsible for the assessment of information that will lead to a regulatory recommendation. In addition,...experience. Minimum of 10 years in Regulatory Affairs . + In depth and relevant Global … more
- Astrix Technology (Houston, TX)
- Global Regulatory Affairs Manager II Regulatory Affairs Houston, TX, US Pay Rate Low: 65.00 | Pay Rate High: 75.72 + Added - 08/03/2024 Apply for Job ... - with complementary businesses in Surgical and Vision Care. ** Global Regulatory Affairs Manager II**...compiling and authoring EU MDR-compliant STeD files. + Independently lead development, remediation, planning, and authoring of EU MDR… more
- J&J Family of Companies (Raynham, MA)
- Senior Regulatory Affairs Program Lead ..., Quality Engineering, Product Management, Labeling, as well as global Regulatory Affairs affiliates. * ... Family of Companies, is currently recruiting for a **Senior Regulatory Affairs Program Lead ** ,...* A demonstrated track record of developing and executing global regulatory strategies that align with business… more
- J&J Family of Companies (Irvine, CA)
- … Affairs Program Lead for International Registration, as part of the Regulatory Affairs Global Execution team, located in Irvine, CA. At Johnson & ... Senior Regulatory Affairs Program Lead - 2406184334W **Description** The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Tech sector… more
- Sanofi Group (Cambridge, MA)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs),...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- AbbVie (Lake Bluff, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - Combination ... submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- System One (Florham Park, NJ)
- Title: Manager/Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP Leading ... located in NJ is hiring a Manager/Senior Manager US Regulatory Affairs - Global Development...and requirements. + Ability to simultaneously plan, coordinate and lead activities on multiple projects. + Ability to self-direct… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Molecules is responsible for Gilead's global portfolio of small molecule products in CMC Regulatory Affairs . This position will lead a global group ... report directly to Head of CMC Regulatory Affairs at Gilead. **JOB DESCRIPTION** + Lead ...affairs goals and contribute to the development of global regulatory initiatives. + Lead … more
