- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the ... meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards,… more
- Takeda Pharmaceuticals (Boston, MA)
- …monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage with CPMQ ... continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the CPMQ team… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in the… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting ... quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and submission...Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Associate Director , Human Factors & Usability Engineering **Location:** Cambridge, MA, Morristown, NJ **About the job** We deliver 4.3 billion ... push the boundaries of what's possible. **Role Overview:** The Associate Director will be responsible for leading...teams to implement HFE best practices + Oversee regulatory compliance and documentation This role offers the opportunity to… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... the compliance of deviation management and serious breach process. This...of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA and ICH. + Experience must… more
- Nanobiosym, Inc. (Cambridge, MA)
- Cambridge, MA, USA | Other General Counsel & Internal Legal VP/ Director / Associate Are you a dynamic, versatile, and experienced legal expert ready to lead the ... to tackle a wide range of legal, regulatory, and compliance challenges. The ideal candidate is a skilled negotiator,...FDA , IRB approvals, and liability management). + Oversee compliance with all applicable laws and standards (state, federal,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the ... of global cross-functional teams which require experienced interpretation of applicable EMA/ FDA /ICH/WHO/Global regulations to ensure CMC compliance within the… more