- 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
- 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...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… 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
- AbbVie (Waltham, MA)
- …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
- 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 ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule 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 (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)
- …life-changing therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable ... engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental… 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
- 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
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate corporate personnel is informed of the progress of… more
- Takeda Pharmaceuticals (Boston, MA)
- …and transparency. Function include Global Development Office, Data Science Institute, Global Regulatory Affairs , Procurement, Legal. + Provide insights ... successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.… more
- Sanofi Group (Cambridge, MA)
- …product + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs + CROs + Regulatory affairs + Collaborates with other CRDs within ... was possible. Ready to get started? The Clinical Research Director (CRD) is noted as the **primary clinical expert...tasks. + Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate...prioritize individual and teamwork loads. + Expert knowledge of Global regulatory requirements. + Experience in vendor… more
- Pfizer (Cambridge, MA)
- …leaders and projects team members, including research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... plan, IND, AR, CSR, investigator brochure, statistical analysis plan and regulatory documents. + Foster a transparent environment that encourages strong partnerships… more
- Harvard University (Cambridge, MA)
- …agenda. The RA position reports directly to faculty supervisors, Program Director , and administrative manager in the Research Staff Services office. The ideal ... potential for re-appointment for the following year. All HBS RA roles are structured as one-year appointments. This is...new theory and related curriculum, and involvement with the senior leaders in business. The position is ideal preparation… more
- Danaher Corporation (Boston, MA)
- …address the world's biggest health challenges. We are seeking an experienced and dynamic Senior Director of Alliance Partnering to join HemoCue in the medical ... + Work closely with internal stakeholders, including sales, marketing, product development, regulatory affairs , and legal teams, to ensure alignment and… more