- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- GRAIL (Boston, MA)
- …teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. ... with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports,… more
- Baystate Health (Springfield, MA)
- …- Maximum $162,800 - $226,100 **Position Summary:** The **Vice President of Safety and Regulatory Affairs ** is a senior executive responsible for leading the ... of delivering safe, high-quality, and patient-centered care. The VP of Safety and Regulatory Affairs also directs development and implementation of a system wide… more
- Boston University (Boston, MA)
- ** SENIOR FINANCIAL REPORTING ANALYST, FINANCIAL AFFAIRS , Comptroller's Office** **Job Description** ** SENIOR FINANCIAL REPORTING ANALYST, FINANCIAL ... Type** Full-Time/Regular Boston University seeks a highly skilled and collaborative Senior Financial Reporting Analyst to support the Office of Financial Operations.… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- As a senior leader within Medical Affairs , the...serve as a strategic thought partner and Chief of Staff to the Vice President of Medical Affairs ... **Strategic Leadership and Execution** + Serve as Chief of Staff to the VP of Medical Affairs ,...a biotech or pharmaceutical setting + Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... alignment of the labeling strategy and labeling content. **Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with TAU/MPD Labeling… more
- Brockton Hospital (Brockton, MA)
- …and technologies for data analysis. This position requires experience in healthcare compliance, regulatory affairs , or a related field, a strong understanding of ... presents reports on compliance activities, trends, and outcomes to senior leadership and governing bodies, while also serving as...the organization to promote and support a culture of regulatory compliance and patient and staff safety.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... **Job Description** This role collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all… more
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