- Merck (Boston, MA)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... drive our strategic priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development and… more
- Harvard University (Cambridge, MA)
- …protected by law.Job Summary:The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) ... more years work experience in government, government relations, or regulatory affairs , preferably in a state or...The Senior Manager for Intergovernmental Policy and Regulatory Affairs brings significant knowledge of state… more
- Bausch + Lomb (Boston, MA)
- …the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain as appropriate in a ... company functions during Regulatory Authority inspections. + Serve as Regulatory Affairs representative on facility/site Local Change Management Boards. +… more
- System One (Burlington, MA)
- Title: Senior Regulatory Affairs Specialist-Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: ... animal tissue suppliers Responsibilities: Will report to the VP of Regulatory Affairs Responsible for managing all activities/tasks related to animal tissue for… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... pipeline and drive our strategic priorities. The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development and implementation of… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Affairs CMC Submission Management where you will support the ... post-approval tasks for assigned products. Work in alignment with RA CMC member on Regulatory , Pharmaceutical Development,...manage multiple and simultaneous projects. As part of the Regulatory Affairs CMC team, you will report… more
- Takeda Pharmaceuticals (Boston, MA)
- …for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D ... regulatory data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic, portfolio,… more
- Fresenius Medical Center (Lawrence, MA)
- …or equivalent experience + 8+ years' experience in domestic and international Regulatory Affairs in the medical device industry + Experience interacting ... Canada, Europe (CE Mark), Mexico, Asia, etc. + Communicate directly with senior management, economic operators, andregulatory agencieson all regulatory issues. +… more
- 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 state expertise for...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Beth Israel Lahey Health (Boston, MA)
- …Grants management, budget preparation and financial management principles and regulatory requirements. + Previously demonstrated understanding of policy and practice ... governing research compliance within a large institution. + Experience with computer systems required, including web-based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access. **Competencies:**… more
- Harvard University (Cambridge, MA)
- …+ Significant knowledge of, and interest in, current issues in international affairs , research methods and sources, and basic quantitative skills. + Strong ability ... and execution of high-priority Belfer Center initiatives, such as visits by senior leaders, task forces, research projects, and others; + Carrying out and… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… 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
- Takeda Pharmaceuticals (Boston, MA)
- …the Global 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 ...of regulatory CMC development and registration strategies. RA CMC member on Regulatory , Pharmaceutical Development,… more
- LogixHealth (Bedford, MA)
- Location: On-Site in Bedford, MA Pu rp ose: The Senior Administrative Assistant oversees Coding/ Coding Quality policies, procedures and other operational workflows ... quality reports /tableau dashboards + Ac tasS har ePointAdminist ra torforCo di ngPo li c ie s ,...l ity: + Ab ili tytoa dd, tos ubt ra ct , mult iply and di v ide… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead, GI &...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- ICON Clinical Research (Boston, MA)
- …understanding of the medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during internal and external ... Senior Director, Design Control- Cambridge MA- Hybrid ICON...design phases. + Coordinate with cross-functional teams, including R&D, Regulatory Affairs , Quality Assurance, and Manufacturing, to… more
- Integra LifeSciences (Boston, MA)
- …and human resources team as a key partner to the global quality assurance and regulatory affairs organization and operate as a member of the Braintree, MA ... possible and making headway to help improve outcomes. The Senior HR Manager is a member of the HR...exciting opportunity to influence the integration of quality assurance, regulatory affairs and operations to drive a… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... Assist in preparation and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports. + Establishes… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …surrounding departments such as Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs . Involved in several aspects of Post Market ... Degree preferred + 3-5+ yrs. related experience preferred + Certification in Regulatory Affairs program Preferred Knowledge, Skills and Abilities + Has… more