- 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)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... Global Regulatory Affairs and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly complex or multiple… 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
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion… 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
- 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