- Kura Oncology (Boston, MA)
- …will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura's oncology and ... drives decisions and actions. Contribute to the development and implementation of regulatory strategies for assigned projects. Lead and oversee the preparation,… more
- Leica Biosystems (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... Biopharma sector.This position reports to the Director , Regulatory Affairs and is part of the Global...fully remote.In this role, you will have the opportunity to: Lead regulatory strategy and execution for external… more
- State Street Corporation (Boston, MA)
- As the Global Head of Index Business Strategy within the Chief Business Office, you will develop and execute a holistic strategy to grow our index business across ... business and maintaining close connectivity to the competitive environment, regulatory developments and client needs. We seek a candidate...candidate with deep experience in the index business to lead this new team and drive growth across our… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …cycle management This individual will act as the global clinical pharmacology lead on PDT projects and contribute to regulatory submissions and interactions. ... true to the best of my knowledge. Job Description Director , Clinical Pharmacology Cambridge, MA Hybrid Job Posting Description... filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in… more
- Brooks Automation (Chelmsford, MA)
- …to the SVP of Global Customer Operations, with a dotted line to the Director , Global Business Services (GBS) Lead , this role is responsible for defining ... deliver an integrated and efficient customer experience. The Director will lead efforts to transition, optimize, and sustain global Customer Care operations… more
- Randstad (Waltham, MA)
- job summary: Medical Director - Rheumatology ( Global Indication Lead ) Remote | Must be US based (EST or CST time zones) Contract, w2 only | 12 Months Travel ... 20% We are seeking an experienced Medical Director (Rheumatologist) to serve as Global Indication Lead on behalf of a leading sponsor through a full-time FSP… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit Regional/ global Regulatory requirements GCP/ICH Emerging research in designated therapeutic ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …communicating with regulatory agencies. Must have experience in global regulatory submission requirements and processes. Program Leadership ... divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives Accountabilities: Program Leadership : Provides strategic scientific… more
- Alkermes (Waltham, MA)
- …DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. This position ... working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable. Essential… more
- BioSpace (Cambridge, MA)
- …(eg TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. * Hires, manages, mentors, motivates, ... to mechanism of action * Preferably with expertise Neurology or Psychiatry * Regional/ global Regulatory requirements * GCP/ICH * Emerging research in designated… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description The Associate Director , Facilities & Engineering Operations Quality Assurance is responsible for providing quality support and oversight for ... a timely manner. This role will report to the Director of Quality Validation and Engineering within the Vertex...robust corrective actions, and risk communication. Serve as Quality Lead or provide support for projects of varied size… more
- Abcam (Waltham, MA)
- …the value of Abcam's unique reagent portfolio. This position reports to the Director , Partnership Development and is part of the Strategic Partnerships team located ... for affinity reagents. Continuously generate leads with new and existing global partners identifying opportunities for further growth aligning Abcam and Danaher… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US...Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs -...was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global… more
- Takeda Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... CMC related matters. + Proven ability to liaise with Regulatory Agencies, having served as lead in...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
