- AbbVie (Cambridge, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, ... GRS, is responsible for the management of global regulatory leads with product and disease...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... where you will oversee the development and execution of regulatory CMC development and registration strategies. RA ...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will ... assigned products. RA CMC member on the Global Regulatory CMC team. Serve as or...Regulatory CMC team, you will report to a Senior Director and work with stakeholders across… more
- AbbVie (Waltham, MA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director , or Director ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you will… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the best of my knowledge. **Job Description** **Objective / Purpose:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable for ... engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . + Has knowledge of fundamental… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** About the role: Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Regeneron Pharmaceuticals (Boston, MA)
- …leaders, advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision ... The Senior Medical Director , Clinical Development will...key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This… more
- J&J Family of Companies (Boston, MA)
- …Access for the Robotics and Interventional Solutions platforms, reporting to the Senior Director , HEMA for Energy/Endomech/Robotics, will work in close ... Director , Health Economics and Market Access - Robotics... Affairs , Clinical Research, Regional HEMA & Marketing, Regulatory Affairs , HCC and Legal. Specific responsibilities… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate corporate personnel is informed of the progress of… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate...prioritize individual and teamwork loads. + Expert knowledge of Global regulatory requirements. + Experience in vendor… more
- Harvard University (Cambridge, MA)
- …agenda. The RA position reports directly to faculty supervisors, Program Director , and administrative manager in the Research Staff Services office. The ideal ... potential for re-appointment for the following year. All HBS RA roles are structured as one-year appointments. This is...new theory and related curriculum, and involvement with the senior leaders in business. The position is ideal preparation… more
- Danaher Corporation (Boston, MA)
- …address the world's biggest health challenges. We are seeking an experienced and dynamic Senior Director of Alliance Partnering to join HemoCue in the medical ... + Work closely with internal stakeholders, including sales, marketing, product development, regulatory affairs , and legal teams, to ensure alignment and… more