Current jobs related to Senior Director of Global Regulatory Affairs - Cambridge, Massachusetts - Takeda


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    Associate Director Regulatory Affairs CMC Job DescriptionWe are seeking an experienced Associate Director Regulatory Affairs CMC to join our team at PSG Global Solutions Careers. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory CMC strategies for assigned programs.Key Responsibilities:Lead...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...


  • Cambridge, Massachusetts, United States Takeda Development Center Americas, Inc Full time

    Job Opportunity at Takeda Development Center Americas, Inc.We are seeking a highly skilled Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA. As a key member of our regulatory team, you will be responsible for overseeing and executing all regulatory activities for multiple projects, including a complex project in development....


  • Cambridge, Massachusetts, United States Ipsen Pharma Full time

    Job Title: Director, Regulatory Affairs, Rare DiseaseAt Ipsen Pharma, we are seeking a highly skilled and experienced Director, Regulatory Affairs, Rare Disease to join our team. This is a critical role that will be responsible for leading the development and implementation of regulatory strategies for our rare disease products.Key Responsibilities:Develop...


  • Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time

    Job Title: Associate Director, Regulatory Affairs CMCVoyager Therapeutics, Inc. is seeking an experienced Associate Director to lead our Regulatory Affairs CMC team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing global Regulatory CMC strategies to secure approval of our gene therapy products.Key...


  • Cambridge, Massachusetts, United States Ipsen Pharma Full time

    Job SummaryThe Director of Regulatory Affairs will be responsible for developing and implementing regulatory strategies for assigned programs and products. This includes providing regulatory expertise to R&D, Franchise, and Commercial Operations, as well as serving as the interface between these teams and the Global Regulatory Affairs (GRA) organization.Main...


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time

    Job Title: Senior Director, Global Medical Affairs StrategyBicycle Therapeutics Limited is seeking a highly skilled Senior Director, Global Medical Affairs Strategy to join our team. As a key member of the Medical Affairs leadership team, you will be responsible for developing and executing the overall global medical affairs strategy and tactical plans for...


  • Cambridge, Massachusetts, United States Ipsen Pharma Full time

    Job SummaryAs a Regulatory Affairs Director at Ipsen Pharma, you will be responsible for developing and implementing regulatory strategies for assigned programs and products. You will provide regulatory expertise to R&D, Franchise, and Commercial Operations, and act as the interface between these teams and global regulatory authorities. Your goal will be to...


  • Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job Title: Regulatory Affairs DirectorWe are seeking a highly skilled Regulatory Affairs Director to join our team at Proclinical Staffing. As a key member of our Commercial team, you will be responsible for providing regulatory leadership and guidance to ensure compliance with FDA regulations and industry guidelines.Key Responsibilities:Provide regulatory...


  • Cambridge, Massachusetts, United States Ipsen Pharma Full time

    Job SummaryThe Senior Director, US Commercial Regulatory Affairs will lead the development and implementation of regulatory strategies to support Ipsen's commercial operations in the US. This role will be responsible for ensuring compliance with FDA regulations and guidelines, as well as maintaining strong relationships with key stakeholders.Key...


  • Cambridge, Massachusetts, United States Takeda Full time

    About the RoleWe are seeking a highly skilled Senior Director, Global Regulatory Lead, GI to join our team at Takeda. As a key member of our organization, you will be responsible for defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Key...


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time

    Job DescriptionBicycle Therapeutics Limited is seeking a highly skilled Senior Director, Global Medical Affairs Strategy to join our team. As a key member of the Medical Affairs leadership team, you will be responsible for developing and executing the overall global medical affairs strategy and tactical plans for our current and future portfolio.This role...


  • Cambridge, Massachusetts, United States Takeda Full time

    About the Role:We are seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team at Takeda. As a key member of our Regulatory Affairs CMC team, you will be responsible for establishing collaboration with Global CMC teams and leadership through networks and enabling CMC regulatory team's success in meeting goals/objectives.Key...


  • Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    Job OverviewThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.We are seeking a highly skilled and experienced Head of Regulatory...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Associate Director, Regulatory Affairs - CMCAgios Pharmaceuticals is seeking a highly skilled Associate Director of Regulatory Affairs - CMC to join our Regulatory Affairs team. As a key member of our team, you will be responsible for leading CMC regulatory strategy to support global development and lifecycle management.The Impact You Will MakeYou will be...


  • Cambridge, Massachusetts, United States Philips North America Full time

    Job Title: Senior Regulatory Affairs Specialist, OperationsAbout the Role:The Senior Regulatory Affairs Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.This role will primarily support Software as a Medical Device (SaMD) and may include support for ventilators, oxygenators, and...


  • Cambridge, Massachusetts, United States Ipsen Pharma Full time

    Job SummaryThe Senior Director, US Commercial Regulatory Affairs is responsible for leading the team involved in post-marketing regulatory activities to support Ipsen's marketed products in the US. This includes prior approval submissions to FDA Office of Prescription Drug Promotion (OPDP) as required, working with Global Regulatory Labeling to review and...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    Job SummaryWe are seeking a highly experienced and skilled Director, PV Regulatory Affairs to join our team at ONO PHARMA USA. The successful candidate will be responsible for leading our Pharmacovigilance (PV) Regulatory Affairs function, ensuring compliance with regulatory requirements and developing strategies to enhance our PV capabilities.Key...


  • Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    About UsThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.Role DescriptionWe are seeking a highly skilled and experienced Regulatory...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    Job SummaryWe are seeking a highly experienced Director of Pharmacovigilance Regulatory Affairs to lead our PV Regulatory Affairs function. The successful candidate will be responsible for developing and implementing PV strategies, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive business growth.Key...

Senior Director of Global Regulatory Affairs

2 months ago


Cambridge, Massachusetts, United States Takeda Full time
Senior Director of Global Regulatory Affairs

Takeda is seeking a highly experienced Senior Director of Global Regulatory Affairs to lead our team in developing and implementing global regulatory strategies for pharmaceutical products. As a key member of our organization, you will play a critical role in ensuring successful regulatory submissions and compliance with international regulations.

Key Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical products
  • Lead the Global Regulatory Affairs team in ensuring high-quality regulatory filings and compliance with guidelines and regulations
  • Act as a key opinion leader within the company and industry, providing leadership and guidance to the team and collaborating with stakeholders
  • Build and maintain relationships with internal and external partners, ensuring effective communication and dissemination of regulatory information
  • Contribute to creating a positive and inclusive work culture, representing the regulatory function in evaluating new product opportunities
Requirements:
  • Advanced Degree or PhD in Life Sciences or related field
  • 15 years of experience in Pharmaceutical Regulatory Affairs, with expertise in international regulations and policies
  • Strong communication and interpersonal skills, with fluency in English and additional languages a plus
What We Offer:
  • Competitive salary and benefits package
  • Tuition reimbursement and charitable contribution matching
  • Health and wellness programs
  • Generous time off and community outreach programs

Takeda is an equal opportunity employer committed to diversity in the workforce. We are dedicated to transforming patient care and delivering innovative therapies to improve lives. Join us and be part of a collaborative and inclusive workplace where excellence is encouraged and rewarded.