- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead , is responsible for ... 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- … regulatory agencies regarding compliance issues. Directs the development of global regulatory communication processes to include responses to external audits ... and directs regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the… more
- Pfizer (Cambridge, MA)
- …benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead will report to the VP, Medical Dermatology ... Global Franchise Lead . The Senior Medical Director will develop...atopic dermatitis disease care gaps, HCP and patient perspectives, regulatory and market access dynamics and integrate these insights… 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
- 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
- Pfizer (Cambridge, MA)
- …for the development of therapies for multiple medicines in prostate cancer + Lead product specific Global Development Team + Oversee development for multiple ... the program with the external clinical community. Principal Responsibilities: + Lead , develop and execute the strategic development of therapies for multiple… more
- Merck (Boston, MA)
- **Job Description** ** Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director of Medical Affairs (GDMA) for ... to professional organizations, academic or regulatory working teams **Asset Regulatory Management** + Successfully collaborate and lead resolution of … 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
- 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
- Manulife (Boston, MA)
- …Hybrid **Job Description** **Institutional Client Platform Product Manager, Senior Director , Global Institutional, Manulife Investment Management** **Job Title** ... From our environmental initiatives to our community investments, we lead with values throughout our business. To help us...: Senior Director , Global Institutional Client Platform The Institutional… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Global Medical Director COPD (Dupilumab) **Location:** Cambridge, MA or Bridgewater, NJ In order to pursue Sanofi's purpose of "Chasing the ... our Specialty Care Medical Affairs team as the Senior Global Medical Director , Asthma and you'll provide...strategy and expertise. **Main Responsibilities:** + Co-build, develop and lead the execution of the medical strategy for assigned… 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
- Manulife (Boston, MA)
- …**The Opportunity** As the ** Director of Learning & Development** for our ** Global Contact Centre** , you will lead the development and execution of ... around the world. From our environmental initiatives to our community investments, we lead with values throughout our business. To help us stand out, we help… more