- Sanofi Group (Cambridge, MA)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...labeling development and negotiation. We are an innovative global healthcare company with one purpose: to chase the miracles… more
- Rhythm Pharmaceuticals (Boston, MA)
- …for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage ... to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve… more
- ThermoFisher Scientific (Boston, MA)
- …full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical ... Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate cross-functionally with… more
- Sanofi Group (Cambridge, MA)
- …and reports to the Director of Medical Operations. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve ... compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities + Ensure promotional/non-promotional… more
- Sanofi Group (Framingham, MA)
- …relevant experience as Quality Auditor. + Direct experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, ... NJ, Framingham, MA, Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous… more
- Sumitomo Pharma (Boston, MA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- Sanofi Group (Cambridge, MA)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... pharmaceutical companies on marketing, distribution, promotion, scientific exchange, and healthcare professional interactions. This role requires efficient prioritization of… more
- Medtronic (Boston, MA)
- …product approvals. Prepare, submit, and manage regulatory filings across global regulatory agencies based on FDA and EU submissions. Provide expertise on ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...world. **A Day in the Life** Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory … more
- Fujifilm (Boston, MA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... America Corporation, we're redefining innovation across the industries we touch-from healthcare and photography to semiconductors and data storage. With roots in… more