Director, Regulatory Affairs
Company: EQRx, Inc.
Location: Cambridge
Posted on: February 25, 2021
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Job Description:
Regulatory Cambridge, Massachusetts, United, States Full-Time As
a society, we've recognized an increasing need to rethink the value
of best-in-class medicines and make a shift to consider both the
science and the cost, with the goal of expanding access to
high-quality medicines. EQRx believes responsibility can be
revolutionary. Want to make a difference while advancing your
career? Come join a team that is working towards our bold mission
of developing innovative medicines at radically low prices to help
people get the medicines they need. What You'll Do The Director,
Regulatory Affairs will implement the overall Regulatory strategy
for the business and lead the clinical team in the execution of
regulatory strategies for the portfolio of projects and products.
You will be responsible for the coordination, preparation and
review of regulatory submissions (US) for small molecules in
support of clinical trials. You will also be responsible for the
preparation and assembly of documentation required for pre-IND
meetings (PIND), Investigational New Drug Applications (IND),
Investigational Medicinal Product Dossiers (IMPD) and Clinical
Trial Applications (CTA) for initial application and annual
updates. You will review protocol amendments, informed consent form
(ICF) and administrative letters for compliance with FDA. You will
be responsible for supporting cross-functional activities
pertaining to regulatory meetings, including the development of
briefing documents and conduct of meeting rehearsals. You will
ensure regulatory compliance with existing regulatory applications
(e.g. IND maintenance, including submission of Safety Reports,
investigator documentation and Annual Reports) throughout the
trial's duration for research studies involving human subjects. You
will submit SAE reports to FDA and develop and manage timelines for
the preparation of submissions. You will represent Regulatory
Affairs with various internal departments to coordinate activities
and assist in the preparation of regulatory submissions. You will
interact with other project team members to ensure the timely
preparation and receipt of information required for regulatory
submissions. Interacts with internal and external partners as
necessary to support product development. You will communicate with
regulatory authorities (FDA, EMA, HC, etc.) and be knowledgeable of
key global guidance documents, regulations, or directives and
effectively communicate any impact on development programs. You
will maintain the clinicaltrials.gov database for development
products and maintain regulatory documents on secure shared
database. You will also proactively identify potential regulatory
issues and recommends solutions. The Impact You Will Have
SuperpowerWhat's yours? Find the right job for your skills. Stay in
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Cambridge, MA 02139
(617) 315-2255 Two-hour street parking is available. There are also
several parking garages in the surrounding area.
Keywords: EQRx, Inc., Cambridge , Director, Regulatory Affairs, Executive , Cambridge, Massachusetts
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