- Sumitomo Pharma (Cambridge, MA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Takeda Pharmaceuticals (Boston, MA)
- …silos, improve accessibility, and enhance agility across R&D while enabling compliance with regulatory standards such as HIPAA and GxP. + Implement and oversee fit ... insights, enhance decision-making, and drive efficiency across research, clinical, and regulatory functions. + Elevate Technical Skillsets: Serve as a mentor and… more
- Charles River Laboratories (Wilmington, MA)
- …an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of ... products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in… more
- Sanofi Group (Cambridge, MA)
- …while maintaining full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by ... sharing information and answering questions based on approved material within Regulatory guidelines. + Engages with appropriate stakeholders to understand the state… more
- Bristol Myers Squibb (Cambridge, MA)
- …trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease / ... and Communication + Will work closely with colleagues in BMS Research, Development, Regulatory , Medical, Commercial and other key functional areas on a global basis;… more
- Bristol Myers Squibb (Devens, MA)
- …material oversight. Participate in relevant internal and joint governance meetings. + ** Regulatory & Documentation** : Author and review sections of regulatory ... concerning raw material controls. Prepare responses for information requests from regulatory bodies. + **Team Leadership** : Manage and mentor team members,… more
- Sanofi Group (Cambridge, MA)
- …manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines; ... protocol design, execution, dose escalation and safety, information for Regulatory authorities. **Key Internal/External Relationships:** + Internal contacts: Other… more
- Sanofi Group (Cambridge, MA)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to clinical development, taking into consideration the medical, scientific, regulatory and commercial perspectives. They will lead a multi-disciplinary, ... maintain a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or ... regional regulatory agencies and be responsible for clinical pharmacology summary...AND SKILLS:** **Education & Experience** + Pharm D. or PhD with 8+ years of working experience in a… more