- 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)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- Pfizer (Boston, MA)
- …Team(s). As a Director , Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from ... be considered. + Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST. + Advanced knowledge of US… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for...possible. Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As...prescription drugs, biologics, and devices. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead (Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC...and approve regulatory design control deliverables. + Lead and/or support global filing activities for… more
- Pfizer (Cambridge, MA)
- …on doing better for Pfizer's patients and healthcare. **ROLE RESPONSIBILITIES** + Proactively lead the development of the Global HTA evidence generation strategy ... + Lead and supervise the design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies) from concept through publication,… 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
- Caris Life Sciences (Boston, MA)
- …will identify external suppliers as needed to support validation studies and will lead contract development. The Sr. Director will support clinical study ... and/or in collaboration with Clinical Affairs depending on the project. The Sr. Director will also provide technical regulatory guidance to support international… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global regulations to ensure CMC compliance within the organization + Lead regulatory compliance assessment with respect to filing requirements for ... life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you...where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in… more
- Editas Medicine (Cambridge, MA)
- …development and ensure compliance with applicable EMA/FDA/ICH/WHO/ Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions ... trials applications, marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead + Recommend strategies and labeling language for ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that… 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...approvals. Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Sanofi Group (Cambridge, MA)
- …and you'll provide impactful medical strategy and expertise. **Main Responsibilities:** + The Global Medical Director will lead the development and ... **Job title:** Global Medical Director , Amlitelimab **Location:** Cambridge,...Key Performance Indicators (KPIs) related to pre-launch activities + Lead and share pre-launch best practices between countries **About… more
- Bristol Myers Squibb (Devens, MA)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director , Analytical Strategy & Lifecycle Group Lead **Location** ... Director of Analytical Strategy & Lifecycle will lead a team of experienced scientists, both direct and...standards, and comparability studies. In addition, the ASL Associate Director will be accountable for enabling regulatory … more
- Sanofi Group (Cambridge, MA)
- **Job title:** Global Senior Medical Director , Asthma **Location:** Cambridge, MA or Bridgewater, NJ Within the Global Medical Affairs team, we are proud to ... Global Medical Immunology team as the Senior Global Medical Director , Asthma and you'll provide...+ Co-create the IEGP strategy with Medical Evidence Generation Lead and other evidence generation-related functions: Clinical Study Unit… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview The Director , Global Payroll will lead Rhythm's payroll function for ... in accounting, finance and HR. Responsibilities and Duties + Lead Global Payroll function while delivering a...global network of researchers, a track record of regulatory successes and global commercial infrastructure to… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as an Associate Director Translational Biomarker Lead Inflammation/Autoimmune disease, ECD in our Cambridge, MA ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate 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)
- …to build a sustainable and innovative Inflammation disease area pipeline + The Senior Director Rheumatology Disease Research will lead a team of researchers in ... bring life-changing therapies to patients worldwide. **Objective:** + The Senior Director Rheumatology Disease Research will be responsible for driving internal and… more