- Merck & Co. (Boston, MA)
- …Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Merck & Co. (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide clinical ... Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine...mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director, CNS Strategy, Global Medical Affairs is a ... but are not limited to the following: + Represents Global Medical Affairs on extended...and self-improvement + Demonstrates experience interacting with and supporting senior leadership + Ability to champion new ideas or… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of ...or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges that ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...- technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a… more
- Danaher Corporation (Boston, MA)
- …pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in ... Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for… more
- Fresenius Medical Center (Waltham, MA)
- …NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical /clinical development, commercial, and other functional ... for cross-functional teams, ensuring alignment on regulatory strategy and execution across global markets. + Work closely with commercial, clinical/ medical , and… more
- AbbVie (Waltham, MA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for… more
- Edwards Lifesciences (Boston, MA)
- Patients are at the heart of everything we do. As the Senior Director, THV Medical Affairs , you will drive strategy development, evidence generation ... health economics and outcomes research teams ensuring seamless integration of medical affairs initiatives into broader organizational efforts. + Building… more
- Merck (Boston, MA)
- …Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... by: + Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead ... **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead...Advisor and function as the "R" in the core Medical , Legal, and Regulatory review functions within the Commercial… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... you thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
- Takeda Pharmaceuticals (Boston, MA)
- …meetings and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that ... in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience in R&D operations or related field,… more
- Sumitomo Pharma (Boston, MA)
- … Medical Strategy (Prostate Cancer) will be a key member of the Medical Affairs team reporting to the Senior Director, Medical Affairs Strategy. ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused… more
- Sanofi Group (Cambridge, MA)
- …**About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of **relevant ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA...helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards achievement ... influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of global … more
- Cole-Parmer (Franklin, MA)
- Job Title: Senior Product Manager, Job Title: Senior Product Manager, Global Product Management Reports To: VP, Global Product Marketing, ZeptoMetrix ... FLSA Status (Exempt/Non-Exempt): Exempt FLSA Status (Exempt/Non-Exempt Position Summary: The Senior Manager, Global Product Management for Molecular Diagnostics… more
- Pfizer (Cambridge, MA)
- …the Pfizer global strategic initiatives, vaccine product lifecycle management plans, global medical affairs goals, and strategic imperatives overall. The ... as a trusted strategic advisor to the Head of Medical Affairs and other vaccines senior...Global cross-functional teams like Global R&D, Global Medical Affairs , Regional … more
