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2468
svp global regulatory affairs Jobs in Waltham, Massachusetts
SVP Global Regulatory Affairs
Waltham, Massachusetts
Dyne Therapeutics
Company 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...
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Global Regulatory Affairs Lead
Cambridge, Massachusetts
Sanofi
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...
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Manager Global Regulatory Affairs CMC
Boston, Massachusetts
Takeda
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...
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Manager Global Regulatory Affairs CMC Submissions Management
Lexington, Massachusetts
Takeda Development Center Americas, Inc
Takeda 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...
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Senior Vice President
Cambridge, Massachusetts
Beacon 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...
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Manager Global Regulatory Affairs CMC Submissions Management
Lexington, Massachusetts
Takeda
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...
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Associate Director
Cambridge, Massachusetts
Sanofi
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...
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Manager Regulatory Affairs CMC
Cambridge, Massachusetts
Takeda Development Center Americas, Inc
Takeda 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...
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SVP Head of Data Analytics
Waltham, Massachusetts
Dyne Therapeutics
Company 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...
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Regulatory Affairs Director
Boston, Massachusetts
Foundation 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...
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Regulatory Affairs Manager III
Cambridge, Massachusetts
The Fountain Group LLC
The 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...
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Senior Manager
Cambridge, Massachusetts
Editas Medicine
At 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...
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Regulatory Affairs Manager
Boston, Massachusetts
Dennis 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....
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Director Regulatory Affairs
Waltham, Massachusetts
Dyne Therapeutics
Company 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...
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Regulatory Affairs Specialist
Andover, Massachusetts
inSync Staffing
Pay 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...
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Regulatory Affairs Specialist
Andover, Massachusetts
Nesco Resource, LLC
Through 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...
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Manager - Regulatory Affairs
Lexington, Massachusetts
Novo 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...
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US - Regulatory Affairs Specialist
Andover, Massachusetts
TalentBurst, 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....
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Director Regulatory Affairs Vaccines CMC
Boston, Massachusetts
Takeda
Director, 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...
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Senior Director
Boston, Massachusetts
OSI
Senior 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...
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Director Regulatory Affairs Vaccines CMC
Boston, Massachusetts
Takeda
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...
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CMC Regulatory Affairs Program Manager
Cambridge, Massachusetts
Katalyst Healthcares & Life Sciences
Responsibilities: 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....
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Director Global Medical Affairs Lead
Waltham, Massachusetts
Dyne Therapeutics
Company 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...
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Director/Senior Director
Boston, Massachusetts
OSI
Thanks 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)...
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SVP Head of Clinical Development
Waltham, Massachusetts
Dyne Therapeutics
Company 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...
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