- 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 (Concord, NH)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for...partners such as Global Regulatory Compliance, Global Labeling,… more
- Takeda Pharmaceuticals (Concord, NH)
- …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 (Concord, NH)
- …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
- Sumitomo Pharma (Concord, NH)
- …experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based ... the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- Sumitomo Pharma (Concord, NH)
- …, Regulatory Affairs** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- ThermoFisher Scientific (Waltham, MA)
- … regulatory professionals within this business area. **What Will You Do?** + Regulatory lead for the LED business. Partners with business leads to advise ... significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible...global Q&RA system efficiencies to meet customer and global regulatory standards + Reviews and approves… more
- Black & Veatch (Burlington, MA)
- …diverse talents and perspectives to use. **The Opportunity** The ** Global Benefits Director ** will have the opportunity to: + Lead the strategic design, ... ** Global Benefits Director ** Date: Dec 25,...plans, administrators, consultants and systems and create recommendations to lead the organization to one unified global … more
- Western Digital (Concord, NH)
- …will oversee and optimize our organization's payroll processes. As the Director of Global Payroll Services, you will lead and mentor the global payroll ... and ability to partner effectively across the organization. **Key Responsibilities:** . Lead global 20-person payroll team with regional managers for compliant… more
- Takeda Pharmaceuticals (Concord, NH)
- …of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in...Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them + Perform tasks of… more
- Takeda Pharmaceuticals (Concord, NH)
- …development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, ... evidence generation sub team for products under development, and working with global , regional and local cross-functional colleagues lead the development of… more
- Chemours (Concord, NH)
- …modern advancements and more sustainable solutions depend on Chemours chemistry. The **Leader of Global Product Management** will lead and mentor a team of ... Global Product Managers and Global Quality in the Thermal Specialized Solutions business at...and external partner assets to achieve business goals + Lead efforts to drive variable cost productivity, assess competitive… more
- ThermoFisher Scientific (Waltham, MA)
- …member of the Global Quality Leadership team, reporting to the Vice President, Global Quality, Regulatory and EHS. The incumbent will ensure that the overall ... implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and… more
- Novo Nordisk (Lexington, MA)
- …medical/ scientific documents, safety monitoring, and data analyses. The Senior International Medical Director will also take medical lead in the development and ... About the Department Our East Coast Global Development Hub brings together the best minds...make a difference? The Position The Senior International Medical Director serves as a subject matter expert for our… more
- Merck (Concord, NH)
- …reporting and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory ... of our Company's Research Laboratories is seeking a curious and collaborative Director to support our rapidly expanding ophthalmology pipeline. As a director… more
- Novo Nordisk (Lexington, MA)
- …to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead / Director /Senior Director - Safety ... Safety Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of… more
- Bristol Myers Squibb (Devens, MA)
- …through the testing and release process. + Supports clinical and commercial global regulatory filings and authors/ reviews/approves portions of the filings ... strategy and standards related to analytics. + Direct experience managing interactions with global regulatory agencies and in the preparation of regulatory … more
- Cambrex High Point (Waltham, MA)
- …review, testing, disposition OOS and deviation management. + Ensure compliance with global regulatory requirements (eg, FDA, EMA, ICH) for API manufacturing ... Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug… more
- United Therapeutics (Concord, NH)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in management ... oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to… more