- Rhythm Pharmaceuticals (Boston, MA)
- …commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Danaher Corporation (Putnam, CT)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… more
- Rhythm Pharmaceuticals (Boston, MA)
- …role with excellent career development opportunities within Global Regulatory Affairs . The position reports into the Director , Global Regulatory ... Overview In support of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory … more
- ThermoFisher Scientific (Waltham, MA)
- …opportunities to make significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible for owning ... Director is able to combine knowledge of scientific, regulatory and business issues to enable products that are...global Q&RA system efficiencies to meet customer and global regulatory standards + Reviews and approves… more
- Takeda Pharmaceuticals (Boston, MA)
- … vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that ... product developmentprogramspreferred + Sound understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development,… more
- AbbVie (Boston, MA)
- …the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. + Participates ... for routine and ad hoc safety monitoring reports to regulatory agencies. Qualifications Scientific Director Qualifications +...required. + 7-10 years of experience in US Medical Affairs with Global Medical Affairs … more
- Merck (Providence, RI)
- **Job Description** The Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and ... work cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area...in a highly matrixed environment is critical. The Executive Director provides strategic and tactical direction to the field… more
- Sumitomo Pharma (Providence, RI)
- …Strateg** **y (** **Hematology/Oncology** **)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also… more
- Sumitomo Pharma (Providence, RI)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide ... **How you will contribute:** + Defines, develops, and leads global strategies to maximize global regulatory...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Boston, MA)
- …across the portfolio of PDT products. **How you will contribute:** + Serves as the global regulatory lead for one or more projects and and includes leadership of ... the Global ...the Global Regulatory Team (GRT) composed of core regulatory ...US FDA and provides support for regional and local regulatory affairs teams for interactions with international… more
- Takeda Pharmaceuticals (Boston, MA)
- …NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs (GRA), Regulatory Operations) to ... NRWS on nonclinical cross-functional teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs)… more
- Textron (Providence, RI)
- **Counsel/ Director , Global Trade Compliance** **Description** **JOB SUMMARY** At Textron, we are a network of global businesses with people who are ... is an exciting opportunity to join the Textron corporate legal team\. The Counsel/ Director , Global Trade Compliance is responsible for \(1\) overseeing the… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **Objectives/Purpose** The Associate Director , Global Medical Communications, Immunology is a key strategic ... partner of the Global Medical Affairs team, responsible for dynamically...assets. In strategic partnership with cross-functional stakeholders, the Associate Director , Global Medical Communications, Immunology will: +… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... of my knowledge. **Job Description** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for… more
- Orchard Therapeutics (Boston, MA)
- Reporting to: Head of Global Medical Affairs Location: Boston, MA, United States Job Summary Senior Director , Medical Communications is a leadership role, ... of Medical Information / Operations. This individual is an integral member of the global Medical Affairs Leadership Team (MALT); works in partnership with the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …adequate support at global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part of due diligence and ... is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. +...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more