- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation ... where you will define, develop and lead global strategies to maximize global ...their regional counterparts. **How you will contribute:** + The Senior Director will be responsible for complex… more
- Merck (Boston, MA)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... drive our strategic priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- … 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 ...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… 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 ... agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- J&J Family of Companies (Boston, MA)
- …the lifecycle of the product and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional functions and ... Associate Director , CMC Regulatory Affairs ...Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson...of a senior member of the CMC RA staff. + Strong knowledge of global … more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and ... of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director...He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills,… more
- Novo Nordisk (Lexington, MA)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the ... you ready to make a difference? The Position The Senior International Medical Director serves as a...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… more
- ICON Clinical Research (Boston, MA)
- Senior Director , Design Control- Cambridge MA- Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to ... fulfil our mission to advance and improve patients' lives. ** Senior Director , Design Control- Cambridge MA- Hybrid**...medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) ... global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism ... and small molecule therapies in **programs focused on respiratory disease.** + The Senior Director of Clinical Research will be responsible for phase 2,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Senior Director , Marketing Operations NA GTMC **Location:** Bridgewater, NJ or Cambridge, MA (Hybrid role) **About the Job** We are an innovative ... up the decision making. We are seeking an experienced Senior Director of Marketing Operations to join...teams, including but not limited to Sales, Marketing, Medical Affairs , Legal, and Regulatory Affairs ,… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... with line management + Supports and/ or leads assigned device-related aspects of global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs,… 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
- J&J Family of Companies (Cambridge, MA)
- …clinical operations, project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical ... Data Monitoring Committee (IDMC) and adjudication meetings as needed + Assists Regulatory Affairs in determining requirements for any corrective actions or… more
- Regeneron Pharmaceuticals (Boston, MA)
- …leaders, advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision ... The Senior Medical Director , Clinical Development will...key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This… more
- Olympus Corporation of the Americas (Westborough, MA)
- …SaaS software solutions and AI algorithms will be highly desired. The Global Senior Product Manager will report to the Director of Global Product ... an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Senior Manager, Global Product Marketing is a member of the Global… more