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svp global regulatory affairs Jobs in Waltham, Massachusetts

  • 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 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 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
  • Senior Vice President

    Cambridge, MassachusettsBeacon Therapeutics (USA) Inc Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote. In this role, you will...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
  • Associate Director

    Cambridge, MassachusettsSanofi About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC RA representative, work with brands on competitively...Full Job Details
  • 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
  • SVP Head of Data Analytics

    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, MassachusettsFoundation Medicine About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion...Full Job Details
  • Regulatory Affairs Manager III

    Cambridge, MassachusettsThe Fountain Group LLCThe Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows: Job Description: Pay: 75.00-86.54/hr on W2. 6-month...Full Job Details
  • Senior Manager

    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
  • 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
  • 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
  • Regulatory Affairs Specialist

    Andover, MassachusettsinSync StaffingPay rate: $38.46/hr Hours: Core hours 10-3, flexible start/finish. 40 hours per week total Location: Andover, MA. Hybrid- Work location address for onsite and hybrid: Mansfield or Andover Duration: 1 year Role Overview : Through coordination/collaboration with direct...Full Job Details
  • Regulatory Affairs Specialist

    Andover, MassachusettsNesco Resource, LLCThrough coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and...Full Job Details
  • Manager - Regulatory Affairs

    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
  • US - Regulatory Affairs Specialist

    Andover, MassachusettsTalentBurst, Inc.Title: Regulatory Affairs Specialist - Labeling - Junior Location: Andover, MA Shift: M-F, 8AM to 5pm Duration: 12+ months Job Description: Role Overview - include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc....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
  • Senior Director

    Boston, MassachusettsOSISenior Director, Regulatory Strategist - Global Regulatory Lead Senior Director, Regulatory Strategist - Global Regulatory Lead (Hybrid) Position Summary PepGen is at an exciting time in our development. Reporting into the VP Head of Regulatory, you will be responsible for...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
  • 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
  • Director Global Medical Affairs Lead

    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/Senior Director

    Boston, MassachusettsOSIThanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. Director/Senior Director, Regulatory Strategist - Global Regulatory Lead Senior Director, Regulatory Strategist - Global Regulatory Lead (Hybrid)...Full Job Details
  • SVP Head of Clinical Development

    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
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