- 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 ... The RA Director is able to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed… more
- Takeda Pharmaceuticals (Boston, MA)
- …global vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Danaher Corporation (Putnam, CT)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory Compliance ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic… more
- CVS Health (Providence, RI)
- …Services division and broader PBM business. This position reports directly to the Director of Medicare Regulatory Affairs . **Duties and Responsibilities:** ... we do it all with heart, each and every day. This Senior Manager, Regulatory Affairs position is a crucial contributor to the Medicare regulatory and… 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 teams to align on Global medical...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 ... and Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also collaborate with company… 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. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Takeda Pharmaceuticals (Boston, MA)
- … Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… 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)
- …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)
- …primary liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies ... interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions. + Ensures… more
- State of Massachusetts (Boston, MA)
- …intended to streamline the permitting and approval process for development projects. The Director of the Permit Regulatory Office will be the point of ... state agencies that issue project permits and approvals. This position will serve as director of the permit regulatory office established within EOED by section… more
- Takeda Pharmaceuticals (Boston, MA)
- …NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs (GRA), Regulatory Operations) to plan, ... NRWS on nonclinical cross-functional teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs) from… more
- Olympus Corporation of the Americas (Westborough, MA)
- …a science-related discipline; Masters preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of 10 years in a ... Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- Chiesi (Boston, MA)
- …Chiesi." **_Who we are looking for_** **Purpose** The position of Associate Medical Director reports to the Head of Medical Affairs Hematology- Immunology ... Medical Director and is part of the Global Medical Affairs team supporting the development and implementation of the products' Global Medical strategy and acting… more
- Organon & Co. (Boston, MA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more
- Humana (Providence, RI)
- … audits and regulatory guidance provided by CMS. The Risk Adjustment Director of Compliance will lead a team tasked with ensuring risk adjustment processes are ... community and help us put health first** The Risk Adjustment Compliance Director ensures compliance with governmental requirements. The Risk Adjustment Compliance … more
- Dana-Farber Cancer Institute (Boston, MA)
- …+ Experience in an academic institution is preferred. + Must have knowledge of regulatory affairs , research ethics and the responsible conduct of research. + ... The Associate Director , Data Analysis and Management, under the Director and the PI of the Cohort Studies, is responsible for the oversight, management and… more