- Takeda Pharmaceuticals (Cambridge, MA)
- …implement processes for the review of Promotional and Disease awareness materials. + Change Management - ability to identify, advocate and implement change ... in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review… more
- Sanofi Group (Cambridge, MA)
- …conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight ... **Job Title:** Director , US Regulatory Affairs - Advertising...movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... approve design control deliverables. + Contribute to product development and lifecycle management planning. + Provide regulatory impact assessments for proposed… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret ... manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or...of performance, and take an active role in leading change . **Strategic Thinking & Problem Solving -** Make decisions… more
- Takeda Pharmaceuticals (Boston, MA)
- … requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. + Oversee master data management for regulatory data and partner/ drive connectivity with RD and ... leadership, and other stakeholders for pipeline realization and post-approval lifecycle management . + Provide standard regulatory reports and dashboards and… more
- GRAIL (Boston, MA)
- …provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with ... when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders...**Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program management… more
- Amgen (Cambridge, MA)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management ** **What you will ... do** Let's do this. Let's change the world. In this vital role you will...and implement strategy for commercial drug product programs, life-cycle management , global regulatory submissions, and variation … more
- State of Massachusetts (Boston, MA)
- …execute decisions quickly, and triage tasks with limited resources. * Effective change management skills, with the ability to persuade, influence, and ... Shattuck Hospital, part of the Massachusetts Department of Public Health (DPH), is seekinga* Director of Facilities Management *to lead a pivotal role in ensuring… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- Director , Training Management Operations Lead The Director , Training Management Operations Lead, is a senior leader within the Learning Center of ... management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- Brightstar Lottery (MA)
- Director Enterprise Risk Management (ERM) Location: Providence, RI, US, 02903IA Statewide, IA, USMD Statewide, MD, USMI Statewide, MI, USKS Statewide, KS, USSD ... . **Responsibilities** We are seeking a strategic and experienced Director of Enterprise Risk Management (ERM) to...the global ERM framework aligned with company strategy and regulatory requirements. + Develop risk appetite statements and risk… more