- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Lead , GI & Inflammation where ... you will define, develop, and lead global strategies to maximize global regulatory...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... develop and lead global strategies to maximize global ...reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types… 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)
- … regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and meetings with … 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
- J&J Family of Companies (Boston, MA)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...plan, assessment aid) documents is preferred. + Knowledge of global regulations, regulatory timelines, guidelines, and … more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Charles River Laboratories (Boston, MA)
- …Boston, MA, San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance** , you will lead regulatory and compliance ... that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance** to join our **Insourcing… more
- Actalent (Boston, MA)
- …to both the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies that maximize probability of success. * Support the ... to generate and refine the product development strategy. * Lead preparation of high-quality global clinical trial...Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Evidence and Outcomes where you will lead the design, conduct, ... the Global Evidence and Outcomes team, you will report to the Director , Global Evidence & Outcomes, Neuroscience. **How you will contribute:** + Collaborates… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Patient-Centered Outcomes, Global Evidence and Outcomes, Oncology where you ... Outcomes (GEO) team, you will report to the Executive Director , Global Evidence & Outcomes Head Oncology....across the lifecycle of drug development with consideration for global stakeholder needs. + Lead strategy development… more
- Olympus Corporation of the Americas (Westborough, MA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Director , Global Health Economics & Market Access is part of Health ... Market Access (HEMA) function and reports directly to Executive Director , Global Health Economics & Market Access....product stages and lifecycles. **Job Duties** + Serve as global and US regional lead for ESE/DU… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are ... regulatory approval as well as product launch and global patient access + have the ability to partner...through all job attributes defined at Takeda + May lead key business initiatives: including evaluating new opportunities and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Associate Director , Global Patient Safety Signal Management and Innovation in Cambridge, ... processes and activities are compliant with EU regulations and EU regulatory authority and inspectors' expectations. You will develop, review, evaluate and… more
- Astellas Pharma (Westborough, MA)
- …global stakeholders. **Essential Job Responsibilities:** + Acts as a CMC regulatory lead and/or Deputy for highly complex projects/products and/or ... CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with local and global stakeholders to… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Translational Biomarker Lead where you will provide scientific and ... of the overall Asset Strategy in the Discovery and Global Product Teams through all stages of clinical development...biomarkers for mechanism of action and drug response. + Lead Translational Biomarker strategy development and execution to support… more
- Takeda Pharmaceuticals (Boston, MA)
- …management or system use; collaborate closely with Training Lead and Systems lead in the Global Publication Center of Excellence. + Supports Publication goal ... and executes operational plans to enhance synergies and efficiencies across Global Publication Center of Excellence and Takeda-wide Publication Business Units and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Job Title** : Associate Director , US 3PL Operations Management Lead (Operations & Analytics) **Location** : ... Lexington, MA **About the role:** As an Associate Director of US 3PL Operations Management Lead (Operations and Analytics), you will provide oversight and… more