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senior manager global regulatory affairs cmc hybrid Jobs in Boston, Massachusetts

  • Director

    Boston, MassachusettsTakedaDirector, Regulatory Affairs Vaccines CMC Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is...Full Job Details
  • Manager

    Boston, MassachusettsTakeda By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information...Full Job Details
  • Director

    Boston, MassachusettsTakeda By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information...Full Job Details
  • CMC Regulatory Affairs Program Manager

    Cambridge, MassachusettsKatalyst Healthcares & Life SciencesResponsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented....Full Job Details
  • Regulatory Affairs Manager

    Boston, MassachusettsDennis Partners Our client is developing precision delivery platforms for the treatment of neurological and oncological disorders. They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements....Full Job Details
  • SVP Global Regulatory Affairs

    Waltham, MassachusettsDyne TherapeuticsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide...Full Job Details
  • Global Regulatory Affairs Lead

    Cambridge, MassachusettsSanofi Global Regulatory Affairs Lead (GRL) Mission statements The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's...Full Job Details
  • Manager

    Cambridge, MassachusettsBiogenJob Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member...Full Job Details
  • Associate Director

    Boston, MassachusettsVertex Pharmaceuticals Associate Director, Regulatory CMC, Cell Therapy Combination Product (Boston) page is loaded Associate Director, Regulatory CMC, Cell Therapy Combination Product (Boston) Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-21730...Full Job Details
  • Director

    Boston, MassachusettsVertex Pharmaceuticals Director, Regulatory Affairs Business Operations (Boston, MA) page is loaded Director, Regulatory Affairs Business Operations (Boston, MA) Apply locations Boston, MA time type Full time posted on Posted 8 Days Ago job requisition id REQ-21405 Job Description General...Full Job Details
  • Associate Director

    Lexington, MassachusettsAccede Solutions IncHybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and with external...Full Job Details
  • Manager

    Waltham, MassachusettsDeciphera PharmaceuticalsJob Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for...Full Job Details
  • Senior Director/Director

    Boston, MassachusettsAstraZeneca PLCDo you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas...Full Job Details
  • Director

    Waltham, MassachusettsDyne TherapeuticsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide...Full Job Details
  • Manager

    Lexington, MassachusettsNovo Nordisk About the Department Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early...Full Job Details
  • Senior Manager

    Lexington, MassachusettsTakeda By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information...Full Job Details
  • Director

    Cambridge, MassachusettsEditas MedicineAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential...Full Job Details
  • Senior Director/Director

    Norwood, MassachusettsCorbus PharmaceuticalsJob Description General Description: As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus' drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable....Full Job Details
  • Director/Senior Manager

    Lexington, MassachusettsConvaTecPioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and...Full Job Details
  • Sr Regulatory Affairs Associate

    Waltham, MassachusettsFresenius Medical CareThis position can be fully remote Global Regulatory experience needed. Demonstrated project management experience needed. PURPOSE AND SCOPE: Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and...Full Job Details
  • Director

    Boston, MassachusettsTakeda By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information...Full Job Details
  • Senior Manager/Associate Director

    Boston, MassachusettsInozyme Pharma Company Overview: Inozyme Pharma,Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical companydeveloping novel therapeutics for the treatment of diseases of abnormalmineralization impacting the vasculature, soft tissue, and skeleton. Throughour in-depth...Full Job Details
  • Regulatory Affairs Manager

    Cambridge, MassachusettsKatalyst Healthcares & Life SciencesResponsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee...Full Job Details
  • Global Lead

    Westborough, MassachusettsOlympusWorking Location: MASSACHUSETTS, WESTBOROUGH Workplace Flexibility: Field Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. Olympus, a leading medical technology company, has focused on making...Full Job Details
  • Regulatory Affairs Associate II Pharma

    Waltham, MassachusettsFresenius Medical CareThe ideal candidate should have US Advertising and Promotion experience. This position can be fully remote. PURPOSE AND SCOPE: Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing...Full Job Details
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