- Merck & Co. (Boston, MA)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Repligen (Waltham, MA)
- OverviewThe Director , Global Payroll will lead the development and execution of Repligen's global payroll strategy tosupport a growing global ... and strategic alignment globally.ResponsibilitiesResponsibilitiesGlobal Payroll Strategy & LeadershipDefine and lead the execution of Repligen's global payroll… more
- Repligen (Waltham, MA)
- …and leading the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner ... implement, and maintain an effective internal control framework that spans all global operations. Lead the SOX compliance program, including risk assessments,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will ... for complex or highly complex or multiple projects. May lead the Global Regulatory Teams...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… more
- AbbVie (Waltham, MA)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead , Director , in PDT R&D: + Serves ... as the global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- … Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- Takeda Pharmaceuticals (Boston, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty...Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** - Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
- Fresenius Medical Center (Waltham, MA)
- …products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the ... strategies, and potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning, preparation, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... Team lead role, prepares and maintains relevant regulatory ...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Bristol Myers Squibb (Cambridge, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Sr. Director , HRBP for Global Regulatory Strategy and Worldwide Patient ... fostering team synergy, and spearheading dynamic change management initiatives. Given the global presence of the client group across multiple BMS locations and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support the Global Health Economics Center of ... appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true to the best of my knowledge. **Job Description** **Objectives/Purpose:** The Director , Global Scientific Communications Lead , Immunology (Anti-CD38 ... anti-CD38 therapy area. In partnership with cross-functional stakeholders, the Director , Global Scientific Communications, Immunology (Anti-CD38 Therapy Area)… more
- Merck (Boston, MA)
- …and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the ... **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is...multiple indications simultaneously + Provide expert advice as the Global Regulatory Lead to Product… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability for collaboration ... best of my knowledge. **Job Description** **Role Objectives:** + The Group Lead , Global Scientific Communications has ultimate accountability for delivering and… more
