Current jobs related to Head of Global Regulatory Affairs Labeling Expert - Cambridge, Massachusetts - Takeda

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Regulatory Affairs Leader

    4 weeks ago

    Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a seasoned regulatory affairs professional to join our growing team at Relay Therapeutics. As a strategic regulatory leader, you will play a critical role in defining and implementing innovative regulatory strategies to accelerate the development and approval of our transformative pipeline.You will serve as the global regulatory...

  • Global Regulatory Affairs Director

    4 weeks ago

    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....

  • Regulatory Affairs Director

    3 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Senior Director, US Commercial Regulatory Affairs Specialist

    3 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

    Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

    About BlueRock TherapeuticsBlueRock Therapeutics is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.Job...

  • Regulatory Labeling Director

    3 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Regulatory Labeling DirectorWe are seeking a highly skilled Regulatory Labeling Director to join our team at BioSpace, Inc. This is a unique opportunity to leverage your expertise in regulatory labeling to drive the success of our respiratory franchise products.Key Responsibilities:Develop and maintain current knowledge of labeling regulations and industry...

  • Regulatory Affairs Strategist

    3 weeks ago

    Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    At Agios Pharmaceuticals, we're seeking a skilled Regulatory Affairs Strategist to join our growing Regulatory team.This individual will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.The successful candidate will prepare and oversee the...

  • Senior Regulatory Affairs Specialist, Operations

    3 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Regulatory Affairs Director

    3 weeks ago

    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...

  • Regulatory Affairs Specialist

    3 weeks ago

    Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Company Overview:Beam Therapeutics is a pioneering biotechnology company dedicated to developing innovative genetic medicines. Our mission is to revolutionize the treatment of serious diseases by harnessing the power of precision genetic editing.We are committed to a values-driven approach, prioritizing cutting-edge science, and a vision of providing...

  • Regulatory Affairs Director

    3 weeks ago

    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...

  • Global Head of Scientific Communication

    3 weeks ago

    Cambridge, Massachusetts, United States Scholar Rock Full time

    Scholar Rock is a biopharmaceutical company dedicated to discovering, developing, and delivering life-changing therapies for people with serious diseases. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily, the company is focused on advancing innovative treatments where protein growth factors play a fundamental role....

  • Regulatory Affairs Lead

    4 weeks ago

    Cambridge, Massachusetts, United States Randstad Digital Full time

    Job SummaryAs a Regulatory Affairs Consultant Lead at Randstad Digital, you will play a critical role in driving a culture of patient safety and quality. You will represent and lead regulatory affairs on enterprise project teams, engaging in strategic discussions with business unit regulatory affairs leaders and specialists to efficiently and compliantly...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Senior Director, Global Regulatory Lead, GI

    3 weeks ago

    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...

Head of Global Regulatory Affairs Labeling Expert

2 months ago

Cambridge, Massachusetts, United States Takeda Full time
About the Role

We are seeking a highly skilled and experienced Head of Global Regulatory Affairs Labeling to join our team at Takeda. As a key member of our Plasma-Derived Therapies (PDT) R&D Organization, you will be responsible for providing guidance and oversight for the global labeling function.

Key Responsibilities
  • Develop and implement global regulatory strategies for the formulation of regulatory labeling strategies for implementation of new and revised prescribing information and packaging.
  • Lead cross-functional teams to facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.
  • Provide regulatory expertise and guidance to internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling.
  • Oversight and accountability for labeling activities managed by external vendor(s) for assigned products.
  • Develop and maintain relationships with regional Regulatory Heads and overseas teams to ensure seamless coordination and timely delivery of high-quality regulatory labeling documents.
Requirements
  • Bachelor's degree in a relevant field, advanced scientific degree (MSc, PhD, or PharmD) a plus.
  • 10+ years of pharmaceutical industry experience, inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.
  • Significant pharmaceutical background with a focus on regulatory and/or both development and post-marketing phases in the US and EU.
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
  • Demonstrated leadership skills and ability to inspire colleagues and influence in a matrixed Environment.
About Takeda

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.