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regulatory affairs manager Jobs in Cambridge, Massachusetts

  • Manager Regulatory Affairs CMC

    Cambridge, MassachusettsTakeda Development Center Americas, IncTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various...Full Job Details
  • Manager Regulatory Affairs

    Boston, MassachusettsFoundation Medicine About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI...Full Job Details
  • Manager Regulatory Affairs

    Boston, MassachusettsApogee Therapeutics Role Summary We are seeking a Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. Reporting to the Executive...Full Job Details
  • Manager Global Regulatory Affairs CMC

    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
  • Manager Global Regulatory Affairs

    Cambridge, MassachusettsTakeda Development Center Americas, IncTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA to Assist the Global Regulatory Lead (GRL) and is accountable for working with regulatory regional leads, other functions and vendors to ensure global...Full Job Details
  • Manager Global Regulatory Affairs CMC Submissions Management

    Lexington, MassachusettsTakeda Development Center Americas, IncTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical...Full Job Details
  • Manager Global Regulatory Affairs

    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
  • Manager Global Regulatory Affairs CMC Submissions Management

    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 Regulatory Affairs Vaccines CMC

    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
  • Director Regulatory Affairs Vaccines CMC

    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
  • Associate Director

    Boston, MassachusettsVertex Pharmaceuticals Associate Director, Regulatory Strategy page is loaded Associate Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22153 Job Description The Regulatory Strategy Associate Director will be...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 Director

    Boston, MassachusettsProClinical Regulatory Affairs Director - Permanent - Boston, MA Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA. Primary...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
  • Regulatory Affairs Director

    Boston, MassachusettsDennis Partners This clinical-stage company is advancing innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director who can develop and execute on global regulatory strategies for a quickly-advancing clinical stage Rare Disease...Full Job Details
  • Director Regulatory Affairs

    Boston, MassachusettsEntrada TherapeuticsThe Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible....Full Job Details
  • Director 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
  • Director Regulatory Strategy

    Boston, MassachusettsVertex Pharmaceuticals Director, Regulatory Strategy page is loaded Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22162 Job Description The Regulatory Strategy Director will be responsible for the development and...Full Job Details
  • Regulatory Affairs Specialist

    Andover, MassachusettsSunrise Systems Inc Job Title: Regulatory Affairs Specialist - Labeling - Junior Job ID: 24-02349 Location: Andover, MA Duration: 12 Months contract on W2 Description: Role Overview Include specific internal and external relationships, product focus, regulatory requirements, physical demands,...Full Job Details
  • Director of Quality Assurance and Regulatory Affairs

    Gardner, MassachusettsPrecision Optics Corporation IncDescription: Overview The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory...Full Job Details
  • Director of Quality Assurance and Regulatory Affairs

    Gardner, MassachusettsPrecision Optics Corporation IncDescription: Overview The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory...Full Job Details
  • Regulatory and Compliance Manager

    Boston, MassachusettsRegulatory Affairs Professionals Society Job Summary The mission of the Harvard T.H. Chan School of Public Health is to advance the public's health through learning, discovery and communication. To pursue the mission, the school produces knowledge through research then translates this knowledge into evidence that...Full Job Details
  • Associate Director / Director

    MassachusettsTreelinebiosciencesAssociate Director / Director, Regulatory Operations & Affairs at Treeline Biosciences (View all jobs) Watertown, Massachusetts, United States About the Role We are seeking a highly skilled, and experienced AD/Director of Regulatory Operations & Affairs to join our growing...Full Job Details
  • Director of Regulatory Affairs

    Boston, MassachusettsClinical Professionals Limited Reference Number: JO-91 Director of Regulatory Affairs (CTR/IND/CTA) Rate: Negotiable Job Type: Permanent Location: Boston CTR/IND/CTA Regulatory Lead A clinical stage biotech offering a global lead position working underneath the Senior Director 2023 has seen the business...Full Job Details
  • Associate Director

    Cambridge, MassachusettsSanofi EU Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs Location: Cambridge, MA or Bridgewater, NJ About the job The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC...Full Job Details
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