- 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 ... work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory...fully remote.In this role, you will have the opportunity to: Lead regulatory strategy and execution for external… more
- 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
- EPM Scientific (Bridgewater, MA)
- …including NDA, ANDA, BLA, OTC, and device categories. Serve as a regulatory lead on cross-functional product development and life-cycle management teams. ... regulatory submissions and responses to health authorities. Collaborate with global regulatory counterparts to ensure regional compliance and integration… more
- Deloitte (Boston, MA)
- …industry perspectives, lead generation materials, and proposals The Team Our Regulatory & Financial Risk offering supports clients' regulatory and compliance ... Senior Consultant, Regulatory Reporting Our Deloitte Regulatory , Risk...As a Senior Consultant, you will collaborate with our global network to support clients and solve complex problems.… 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. ... filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory… more
- State Street Corporation (Boston, MA)
- …(State Street IM) is the fourth largest asset management firm globally. Global Funds Management is responsible for all treasury, fund administration, and reporting ... This includes valuation, board liaison and reporting, financial and regulatory reporting, taxation, expense accruals, service provider oversight, new product… 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 ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Santander Holdings USA Inc (Boston, MA)
- …Country: United States of America Your Journey Starts Here: Santander is a global leader and innovator in the financial services industry. We believe that our ... operational risks associated with digital payments operations, ensuring compliance with regulatory requirements, and contributing to the development of robust risk… 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
- AstraZeneca (Boston, MA)
- …interface Global external awareness within the therapeutic area and global regulatory environment Ability to travel nationally and internationally At ... be based in Boston Seaport. About AstraZeneca AstraZeneca is a global , science-led, patient-focused biopharmaceutical company that focuses on the discovery,… more
- Cognizant Technology Solutions (Boston, MA)
- …analytical, problem-solving, and communication skills. *Demonstrated ability to lead cross-functional teams and manage multiple projects simultaneously. *Familiarity ... with relevant regulatory requirements and validation processes. *Adaptability, attention to detail,...inclusive workplace where everyone can thrive. Cognizant is a global community with more than 300,000 associates around the… 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
- The CERES Group (Boston, MA)
- Join a global compliance team for one of Boston's leading Asset Management Firms. This role will report to the Manager of IT Security and is part of the IT ... staff on products, projects, applications and services as required Participates and lead incidents as part of the Information Security Incident Response Team (ISIRT)… more
- State Street Corporation (Quincy, MA)
- …team members; *Managing virtual projects including team resources from multiple global locations; *Developing and maintaining project schedules and resource plans ... will help you succeed in this role: *Able to work independently and lead working groups; *Strong problem-solving and analytical skills along with close attention to… more
- Vertex Pharmaceuticals (Boston, MA)
- …The Toxicology Senior Research Fellow acts as the Preclinical Safety Assessment (PSA) lead on Research project teams, cross-site teams and steering committees and is ... and PSA leadership in a timely manner. Collaborates closely with the program regulatory toxicologists to ensure a smooth transition into development at the VXc… more
- Vertex Pharmaceuticals (Boston, MA)
- …gap analysis, determining robust corrective actions, and risk communication. Serve as Quality Lead or provide support for projects of varied size and complexity that ... and approval of assigned department and cross-functional processes for continuous improvement. Lead compliance walkthroughs of the site and help drive the closure of… more
- Boston Scientific (Cambridge, MA)
- …methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Your responsibilities include: Lead Quality function ... Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Global Regulatory Lead **Location:** Cambridge, MA , Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Lead (GRL) is the fully accountable decision maker for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy with senior leadership of the TAU ... opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
