- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will ... for complex or highly complex or multiple projects. May lead the Global Regulatory Teams...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- … Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... functional areas. Relationships You will report to the Senior Director , Regulatory Affairs (based in Lexington). Essential...and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed… more
- Takeda Pharmaceuticals (Boston, MA)
- …across the portfolio of PDT products. **How you will contribute:** + Serves as the global regulatory lead for one or more projects and and includes ... patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and...leadership of the Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs (GRA), Regulatory Operations) to plan, ... Represent NRWS on nonclinical cross-functional teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- ThermoFisher Scientific (Waltham, MA)
- … regulatory professionals within this business area. **What Will You Do?** + Regulatory lead for the LED business. Partners with business leads to advise ... significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible...global Q&RA system efficiencies to meet customer and global regulatory standards + Reviews and approves… more
- Wabtec Corporation (Boston, MA)
- …legal support on various environmental, social, and governance (ESG) and product regulatory matters to Wabtec's global operations. The position serves as ... successfully manage multiple projects in a fast-paced environment, and lead cross-functional teams to achieve results. + A commitment...The position will report to the Corporate Vice President, Global EHS & Regulatory within the Legal… more
- Takeda Pharmaceuticals (Boston, MA)
- …implement new capabilities and improve existing processes/systems **_A_** **_CCOUNTABILITIES:_** + The Director (Team Lead ), Global Clinical Supply Chain ... company to inspire you and empower you to shine? Join us as the Director , Global Clinical Supply Chain Planning based in Cambridge or Lexington, MA… more
- Organon & Co. (Boston, MA)
- …**The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible ... are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans....for the execution (in conjunction with the TMED Operations Lead ) and reporting thereof. The Director will… more
- Broadridge Financial Solutions (Boston, MA)
- …helping others along the way, come join the Broadridge team. As the Product Director for Broadridge Regulatory Communications, you will be at the forefront of ... + Work independently, with guidance needed only in complex situations. + May lead functional teams or projects with moderate resource requirements and complexity. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are ... and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global...through all job attributes defined at Takeda + May lead key business initiatives: Evaluates new opportunities and provides… more
- Takeda Pharmaceuticals (Boston, MA)
- …development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, ... integrated evidence generation sub-team for products under development, and work with global , regional and local cross-functional colleagues to lead the… more
- Danaher Corporation (Boston, MA)
- …500 by more than 5,000% over the past 25 years. The Opportunity The Global Compensation Director leads the design, development, implementation, and delivery of ... in support of Danaher businesse s . In addition, the candidate will lead communication, messaging, and training related to compensation programs, and work closely… more
- Takeda Pharmaceuticals (Boston, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. + Advanced knowledge of regulatory ... therapies to patients worldwide. Join Takeda as an Associate Director , Quantitative Clinical Pharmacology Lead in Cambridge,... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more
- Takeda Pharmaceuticals (Boston, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. + Advanced knowledge of regulatory ... you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **OBJECTIVE:** + Serves as a senior-level Global Safety Lead (GSL) and Company-wide patient safety expert for assigned ... Takeda Safety Board and similar forums. The Senior Medical Director will be a key player in the preparation...submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert ... and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety information… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Translational Biomarker Lead Inflammation/ Autoimmune Disease, ECD where ... plans as part of the overall Asset Strategy in the Discovery and Global Product Teams through all stages of clinical development and post-market activities. Secure… more