- EPM Scientific (Bridgewater, MA)
- A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval ... regulatory submissions and responses to health authorities. Collaborate with global regulatory counterparts to ensure regional compliance and integration… more
- Kura Oncology (Boston, MA)
- …will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura's oncology and ... decisions and actions. Contribute to the development and implementation of regulatory strategies for assigned projects. Lead and oversee the preparation, submission,… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …and simulation activities as appropriate for the project. Contribute to regulatory documents including Investigator Brochures, Labeling and those required ... true to the best of my knowledge. Job Description Director , Clinical Pharmacology Cambridge, MA Hybrid Job Posting Description...life cycle management This individual will act as the global clinical pharmacology lead on PDT projects and contribute… more
- BioSpace (Cambridge, MA)
- …to mechanism of action * Preferably with expertise Neurology or Psychiatry * Regional/ global Regulatory requirements * GCP/ICH * Emerging research in designated ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit Regional/ global Regulatory requirements GCP/ICH Emerging research in designated therapeutic ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... progress. The Associate Director , Global Regulatory Affairs - Global Labeling ... function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements (FDA,… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Technologies (RIM systems, publishing tools, global submission management, labeling platforms, IDMP readiness). Pharmacovigilance ... Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting… more
