- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- AbbVie (Waltham, MA)
- …LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Merck (Boston, MA)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development and implementation… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , Global Regulatory Affairs in Cambridge, MA with the ... following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience. Prior… more
- AbbVie (Cambridge, MA)
- …Development and Pipeline cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Reviews, assesses and reports ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- AbbVie (Waltham, MA)
- …Will consider remote candidates. Purpose: The Associate Medical Director /Associate Scientific Director provides specialist medical/scientific strategic ... and operational input into core medical affairs activities within their TA inclusive of healthcare professional/provider interactions; generation of clinical and… more
- Philips (Cambridge, MA)
- **Senior Director of Clinical Affairs ** Delivers clinical knowledge, experience and expertise across the whole value chain from ideation to end-of-life. Focus in ... on key relevant clinical topics to support strategy development and strategy execution. + Build Clinical Affairs , Market Access and outcomes research… more
- AbbVie (Cambridge, MA)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. Join Takeda as an Associate Director , Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device ... the Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is...ensure submission acceptance and approval + Manages the device regulatory strategy of high quality and compliant… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation... strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and...through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (Boston, MA)
- …+ Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as a key member of ... the strategic direction of the company's product pipeline and regulatory strategy . + Drive operational excellence initiatives...+ 10+ years of experience in device quality, device regulatory affairs , or a related field within… more
- Takeda Pharmaceuticals (Boston, MA)
- …FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Veterans Affairs, Veterans Health Administration (Manchester, NH)
- …care system. Responsibilities This position is located in the Office of the Director of Manchester VA Medical Center and reports to the Chief Compliance Officer ... that reports to the Medical Center Director . Duties include, but may not be limited to...in advance potential slippage or increased costs. Understanding local strategy , local needs, and risks of the local health… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... true to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals (Senior/Executive Director ) OBJECTIVES/PURPOSE + To… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... publications best practices and the development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications… more
- Cardinal Health (Boston, MA)
- …consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing ... selling to Pharmaceutical, Biotech and Medical Device companies client preferred. + Regulatory affairs , drug development understanding is highly preferred. +… more