- 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: 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
- Merck (Boston, MA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or... Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… 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
- Novo Nordisk (Lexington, MA)
- …Presidents and other colleagues across global R&D. The Nonclinical Project Director will lead nonclinical project teams. Essential Functions + Manage the ... for clinical trial applications, regulatory interactions, and market registration to global regulatory authorities (eg IB, pre-IND, IND/CTA and NDA/MAA) +… 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
- J&J Family of Companies (Cambridge, MA)
- …Clinical Development and Clinical Pharmacology experience is preferred. + Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is ... Associate Director , Translational Clinical Medical Lead Translational...relevant stakeholders at the CDT. The TCML collaborates with Global Development Operations (GDO) and the entire Trial Team… 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
- 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 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
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Global & US Medical Content Lead will plan and deliver an end-to-end medical channel content strategy across Pfizer medicines and ... + Lead the planning, conceptualization, production, and dissemination of Global & US medical content across internally and externally-facing medical channels,… more