- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA ... with the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed Products in ... EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- Sanofi Group (Cambridge, MA)
- **Job title: Senior Manager , US Advertising & Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** Under ... thought was possible. Ready to get started? **Main responsibilities** + Represent Global Regulatory Affairs (GRA) US AdPromo as a member of cross-functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global ... therapies to patients worldwide. Join Takeda as a Senior Manager , Regulatory Affairs Project Management...and Strategic Planning where you will Partner with the Global Regulatory Lead (GRL) on Global… more
- Editas Medicine (Cambridge, MA)
- …leading the way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs , you will play a critical role in ... in clinical development. You will collaborate closely with the global regulatory lead and cross-functional teams to...commercialization of our products. Key Responsibilities: As the Senior Manager , Regulatory Affairs , you will… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and ... develop CMC regulatory strategy for global vaccine programs in...various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote Global Regulatory experience needed. Demonstrated project management experience needed. **PURPOSE AND SCOPE:** Ensures company ... products meet regulatory requirements by supporting all assigned regulatory ...of understanding of functions. + May escalate issues to supervisor/ manager for resolution, as deemed necessary. + Mentor other… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... awareness of recent in-class approvals. Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with… more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... Administration Position Description: The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …more of the following Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations, ... The Business Analysis & Operations Senior Manager will drive consistency across the Global...Quality. Experience working within and knowledge of GXP/GCP and regulatory ICH 6 guidelines. Strong knowledge of technologies such… more
- AbbVie (Waltham, MA)
- …products 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
- Pfizer (Cambridge, MA)
- …and flu vaccines, antivirals, and diagnostic assets. The Global Scientific Affairs COVID & Flu Senior Manager will deliver timely feasibility assessments, ... evolve, standards and procedures. The Global Scientific Affairs COVID & Flu Senior Manager will...and other Vaccines-relevant experience is highly desired. + Understanding global regulatory guidance for appropriate use and… more
- embecta (Andover, MA)
- …components - is designed to support the varying needs of our diverse and global employees. The Senior Manager , Systems Engineering will provide leadership to ... embecta is a global diabetes care company that is leveraging its...peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory… more
- ThermoFisher Scientific (Waltham, MA)
- …on US and Canada + Ensure strategic pharmacovigilance support in the region to Regulatory Affairs , Medical Affairs , US Commercial function, and the broader ... the region. Assess current processes to ensure adherence to US safety regulatory requirements and where needed enhance and/or develop new processes while assuring… more
- Cathay Pacific Airways Limited (Boston, MA)
- Airport Operations Manager + ASD - Airport Services Delivery + Boston, Massachusetts, USA + Cathay Pacific + Application Deadline28 Jun 2024 Company Description Move ... our Hong Kong heritage but equally proud of the global , diverse workforce that makes us who we are....station, employees and suppliers are fully compliant with all regulatory requirements and quality standards + Achieve absolute operational… more
- Actalent (Boston, MA)
- …+ Partner and collaborate globally with cross-functional teams including Compliance, Legal, Regulatory Affairs , and Clinical Management. + Partner with internal ... will play a pivotal role in developing and maintaining outsourcing plans, global study budgets, Key Performance Indicators (KPI's) and metrics for CRO's and… more
- Harvard University (Cambridge, MA)
- 66094BRAuto req ID:66094BRJob Code:361060 Administrative Manager Department Office Location:USA - MA - Cambridge Business Title:Director, Program on Emerging ... Technology, Scientific Advancement & Global PolicySub-Unit: Salary Grade (https://hr.harvard.edu/salary-ranges#ranges) :060Time Status:Full-time Union:00 - Non… more
- Philips (Cambridge, MA)
- …key audiences. + Partner with clinical business teams, clinical science, clinical affairs , legal and regulatory to ensure compliance of marketing ... clinics, and radiology centers. **Your role:** As the Senior Product Marketing Manager for Radiology Informatics (RI), you will be responsible for new product… more
- Actalent (Boston, MA)
- Description: The Business Development Manager (BDM) is responsible for hunting new business within the vertical and segments assigned, along with bringing an ... and Diagnostic companies with Clinical Operations, Auditing, Quality, and Medical Affairs business opportunities * Qualify high value and high potential business… more