- Takeda Pharmaceuticals (Boston, MA)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- 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
- Sanofi Group (Cambridge, MA)
- …families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs (GRA)-Advertising and Promotion ... This role is responsible for overseeing several activities for Global A-P including but not limited to: + Lead...initiatives and associated cross-functional teams + Lead GRA A-P regulatory deliverables in support of technology evolution, and Gen… 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- …might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for investigational and ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory ...position you will build and lead a cell medicine regulatory affairs team and provide regulatory… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Director , US Regulatory Affairs ...area, you will be considered the resident expert in Global Regulatory Affairs Region NA, ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Senior Director Kevzara **Grade:** L4-2 **Location** : Cambridge, MA **About the Job** In order to pursue Sanofi's ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...that address highest unmet needs. We are an innovative global healthcare company, committed to transforming the lives of… 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
- Merck (Boston, MA)
- **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 (Boston, MA)
- …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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Medical Affairs Director - Evidence Generation, Respiratory **Location:** Cambridge, MA Our Medical function serves as a valued strategic partner ... with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support...improve the lives of patients. We are an innovative global healthcare company with a focus on immunology that… 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
- Sanofi Group (Cambridge, MA)
- …thought was possible. Ready to get started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising & ... **Job Title** : Senior Director , Global Regulatory Advertising...assigned. **About You** **Experience** + Successful track record in Regulatory Affairs with 7 -10+ years of… 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
- Novo Nordisk (Lexington, MA)
- …across multiple functional areas. Relationships You will report to the Senior Director , Regulatory Affairs (based in Lexington). Essential Functions ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Sanofi Group (Cambridge, MA)
- …decision-making. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Sanofi Group (Cambridge, MA)
- …Market + Track record of successful cross-functional collaboration + Familiarity with global regulatory environments and requirements + Experience in lifecycle ... **Job title** **_:_** Global Medical Senior Director Dermatology and...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more