- Design and implement regulatory strategies for clinical trial applications
- Oversee, create and submit regulatory filings for assigned programs
- Acting primary representative for all external and internal partnerships, and regulatory communication
- Arrange and lead meetings with global health authorities
- Bachelor's degree in Life Sciences or related fields required; advanced degrees such as a PhD in biomedical sciences or related fields preferred.
- Minimum of 10 years of experience in the biopharmaceutical industry, with at least 5 years in a regulatory strategy role.
- Experience supporting clinical development teams in the autoimmune disease space is a must
- Experience in Oncology and Immuno-oncology is preferred but not required
- Expertise in regulatory submission structure and content (e.g. IND, CTA, MAA, NDA, BLA)
- Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
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Gilead Sciences Boston, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to dev ...
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Fairway Consulting Group Massachusetts, United StatesOur client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs. Major tasks and responsibilities include:Supports global regulatory strategy and execution on development programs, including maintainin ...
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Dennis Partners Boston, MA, United States FreelanceOur 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. Reporting int ...
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Foundation Medicine Boston, United States Full timeAbout 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 diagn ...
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Randstad North America, Inc. Cambridge, United StatesAs a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: 1. Advise internal stakeholders (marketing, manu Regulatory Affairs, Specialis ...
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Randstad Cambridge, United Statesregulatory affairs specialist (cambridge). · cambridge , massachusetts · posted 3 days ago · job details · summary · $65 - $80 per hour · contract · bachelor degree · category computer and mathematical occupations · reference · job details · job summary · Your Respons ...
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PSG Global Solutions Careers Cambridge, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Manager of Regulatory Affairs, working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States. · Works ...
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Philips Cambridge, United States Full timeJob Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
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Randstad Cambridge, United Statesjob summary: · Your Responsibilities: · As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: · 1. Advise internal stakeholders (m ...
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Head of Regulatory Affairs
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Flagship Ventures Somerville, United StatesWhat if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way? · What if · you could be the first hire in Regulatory Affairs with the ...
Sr. Director, Clinical Regulatory Affairs - Boston, United States - Birdseye Partners
Description
Our client is seeking a Sr. Director, Clinical Regulatory Affairs to develop regulatory strategies for both non-clinical and clinical programs and lead interactions with regulatory authorities. Reporting to the SVP, Head of Regulatory Affairs, this role will have significant strategic oversight of various submissions and will be the global regulatory lead for assigned programs for the company.
Responsibilities:
Qualifications: