- Aequor (Waltham, MA)
- …drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our ... software, equipment, and chemical requirements is an advantage.Primary Responsibilities: Lead by example to promote an inclusive, motivating work environment… more
- Takeda Pharmaceuticals (Boston, MA)
- …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 success towards achievement of program objectives for complex and/or multiple… more
- AbbVie (Waltham, MA)
- …Facebook, Instagram, YouTube and LinkedIn. 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Bridgewater, NJ / Cambridge, MA (hybrid) **About the Job:** Are you ready to shape the future of ... accelerate progress. Join our Immunology & Inflammation Regulatory Team as Global Regulatory Lead and you'll be responsible for the development &… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Lead Oncology where you will contribute to ... more complex programs. May lead working groups and represents Global Regulatory Team (GRT) at project team meetings. Provides strategic and tactical guidance… 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)
- …The Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... with immunologic, hematologic, and other complex diseases. The Director, Global Labeling Strategy Lead is a key...Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- JPMorgan Chase (Boston, MA)
- …base. + Design and run the global client engagement agenda + Work with the Global Regulatory Lead and Product to plan and execute the transition to use ... solutions to our institutional clients, adapting to evolving regulations and influencing the global regulatory framework that supports our products. You will act… more
- ThermoFisher Scientific (Waltham, MA)
- …purchasing convenience and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and ... activities revolve around developing and maintaining the team's capabilities for regulatory activities that support the LPE business portfolio throughout its product… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC. **How you will...Authorities, as required. + Proven ability to liaise with Regulatory Agencies, having served as lead in… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of ... 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)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... partners such as Global Regulatory Compliance, Global Labeling,...conducive to goal achievement. + Must be able to lead cross-functional and cross-regional teams and deliver results in… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the...lead complex outsourcing projects. + Deep understanding of regulatory information management + Savvy and effective negotiation skills… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** ** Global Device & Patient Experience Lead , Facilitated or Conventional Subcutaneous ... devices to market. **_ACCOUNTABILITIES_** + Contribute to the development and lead implementation of global go-to-market strategies, positioning, messaging, and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …R&D functional strategies including clinical, regulatory , GEO, safety, compliance. Lead development and execution of multi-year global medical strategy for ... in order to bring life-changing therapies to patients worldwide. Join Takeda as Global Medical Affairs Lead , Plasma-Derived Therapies Innovations where you will … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Head of US Commercial & Global Brand Lead , Alphamedix **Location** : Cambridge, MA **The Head of US Commercial & Global Brand Lead , ... of Radio Ligand Therapy in NET and beyond. As ** Global Brand Lead ** you will be accountable...will include managing the increasingly challenging access environment, the regulatory approval process, an increased focus on compliance and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oncology including Clinical, Drug Discovery, Clinical Pharmacology, Companion Diagnostics, Global Regulatory Affairs, Biomarker Sciences and Technologies, ... and empower you to shine? Join us as a Global Translational Lead in our Cambridge office....target product profile and launch plans + Partner with Regulatory Affairs and ensure appropriate biomarker elements are incorporated… more
