- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Regulatory Project Management, GI 2 within our ... Global Regulatory Teams (GRTs) to ensure global regulatory project plans for...TRAVEL** + Remote within the US + Travel: The Director is expected to come to Quarterly GRA meetings… more
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Novo Nordisk (Lexington, MA)
- …medicines for patients. The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...Essential Functions + Serve as a member of the Global Project Team (GPT) utilizing precedent and… more
- Novo Nordisk (Lexington, MA)
- …and frequent interaction with Project Vice Presidents and other colleagues across global R&D. The Nonclinical Project Director will lead nonclinical ... a project . About the Position As Nonclinical Project Director you will be heading nonclinical...applications, regulatory interactions, and market registration to global regulatory authorities (eg IB, pre-IND, IND/CTA… more
- Medtronic (Boston, MA)
- …Medtronic's Robotic technologies to market. It involves creating, managing and executing global regulatory strategies for new product development as well as ... future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the... global markets. This position will interact with global regulatory authorities and global … more
- Takeda Pharmaceuticals (Boston, MA)
- …order 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...and/or lead agency meetings on CMC topics. + Ensure project team colleagues, line management, and key stakeholders are… more
- Cardinal Health (Boston, MA)
- … experts who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Editas Medicine (Cambridge, MA)
- … regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are ... trials applications, marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory… more
- Sanofi Group (Cambridge, MA)
- …with Sanofi standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment ... post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Sanofi Group (Cambridge, MA)
- …with Sanofi standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment ... activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Gilead Sciences, Inc. (Boston, MA)
- …Description Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... ability to rapidly learn new therapeutic areas. + Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to… more
- Sanofi Group (Cambridge, MA)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with ... impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director ... intelligence reports or deliverables as it relates to project or process strategies to further regulatory … more
- IQVIA (Boston, MA)
- …deliverables outsourced to the CRO. Is primary point of contact for the assigned Project Director /Manager from the CRO responsible for the trial. * Ensures that ... Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners, to… more
- Bristol Myers Squibb (Cambridge, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Scientific Associate Director , DMPK Project Representative** Challenging. Meaningful. ... the globe. PCO is looking for a Scientific Associate Director to join the Dev DMPK group that is...briefing books, DSUR, etc. to support clinical trials and global drug registrations. Interacts with regulatory authorities… more
- Takeda Pharmaceuticals (Boston, MA)
- …oncology opportunities for either partnering and/or investment. + In collaboration with Global Regulatory Affairs (GRA), monitor and communication with Takeda ... Identify, monitor and review near-term (within 3 years of regulatory approval) oncology partnering opportunities + Lead / co-lead...the Takeda Oncology BD strategy + In collaboration with Global Product / Project Teams and … more
- Sanofi Group (Cambridge, MA)
- …dermatologic, respiratory, and gastrointestinal diseases. **Main Responsibilities:** The Global Medical Immunology Pipeline Associate Director , Gastroenterology, ... **About the job** **Our Team:** At Global Medical Immunology, we support Sanofi's commitment to...curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to… more
- Sanofi Group (Cambridge, MA)
- …for chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** The Global Medical Director of the Dermatology, reports to the ... **Our Team** : This role reports into the Global Medical Immunology team that is part of...function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to… more
- Sanofi Group (Cambridge, MA)
- …chronic dermatologic, respiratory, and gastrointestinal diseases. **Main responsibilities:** The Global Medical Director of the Dermatology, Atopic Dermatitis ... **Our Team** : This role reports into the Global Medical Immunology team that is part of...function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to… more
- Merck (Boston, MA)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point… more
- MKS Instruments Inc (Andover, MA)
- …while identifying synergies, prioritized harmonization, applying best practices, ensuring regulatory and reporting compliance across the company's global ... for the assessment, design, development and implementation of an organization-wide global benefits philosophy spanning a variety of benefit programs, including but… more