Regulatory Affairs Manager- CMC
Company: Intellia Therapeutics
Location: Cambridge
Posted on: June 1, 2021
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Job Description:
Why Join Intellia? Our mission is to develop curative genome editing treatments
that can positively transform the lives of people living with
severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore,
Disrupt, Deliver and feel strongly that you can achieve more at
Intellia. We have a single-minded determination to excel and
succeed together. We believe in the power of curiosity and pushing
boundaries. We welcome challenging thoughts and imagination to
develop innovative solutions. And we know that patients are
counting on us to make the promise a reality, so we must maintain
high standards and get it done. We want all of our people to go beyond what is possible. We
aren't constrained by typical end rails, and we aren't out to just
"treat" people. We're all in this for something more. We're driven
to cure and motivated for change. Just imagine the possibilities of
what we can do together. How you will Achieve More with Intellia: As a Manager joining our growing Regulatory Affairs team, you
will provide critical support to Intellia's in-vivo and ex-vivo
programs, independently managing your own program while also
contributing towards others. Given the breadth of work on this
team, the candidate will have the opportunity to explore a wide
range regulatory challenges that support Intellia's gene editing
pipeline. The principal role you will fulfill will be: Work with the Senior Director for CMC to Prepare and/or
coordinate regulatory submissions for Intellia's investigational
therapeutics in the US, EU and other jurisdictions. Build on newly established submission review processes and
promote these in future submission activities with the Tech-Ops
group. Demonstrate flexibility To handle large multicomponent Module 3s
establish good working relationships with Tech-Ops SMEs under tight
deadlines Be collaborative and communicative with Regulatory colleagues
and with functional SMEs A solid basis of understanding of 21 CFR 600 biological product
regulations is important. You will be encouraged to Initiate or contribute to the
Regulatory teams efforts for work process improvements which have
an impact on the working of the Regulatory Affairs function or
other departments. For example supporting the introduction of
RIMS. Work closely with Technical Operations including pharmaceutical
development, analytical development and manufacturing as well as
with Quality and where applicable with external partners to deliver
the CMC components for regulatory filings This is a unique role that will provide you with opportunities
to broaden your regulatory experience in gene therapy and cell
therapy regulations for US and EU territories, and participate in
efforts to define regulatory approaches for the new field of CRISPR
technology products. About You: If you are looking to immediately become a key contributor on a
team where you have an equal voice, this is opportunity is for you!
We are looking for a candidate with B.S. degree in a life science
discipline and a minimum of 3-4 years relevant experience in CMC
Regulatory Affairs. Meet your Future Team: The Regulatory team is growing quickly! We have expanded from a
single person to a team of 5 over the last year. This is an
exciting time to join us, as we are starting to build out a
regulatory infrastructure that will be needed to support our
ambitious regulatory and clinical goals for our investigational
products. The team is small, friendly and genuinely enjoy working
with each other (some may even say we have great chemistry!) We are
a passionate group of individuals on a mission to pioneer the
approval of CRISPR therapies. The team is currently working off-site during the COVID
pandemic. As the situation improves there are plans to meet once or
twice a month as a regulatory group with the flexibility for to be
on site as much as you prefer. If you join our team, you can expect
to join a hardworking and collaborative environment. We look
forward to fostering your skills, learning from your experiences,
and building a larger team that will make a difference in patients'
lives. #LI-KD1 EEOC Statement: Intellia believes in a diverse environment, and
is committed to equal employment opportunity for all its employees
and qualified applicants. We do not discriminate in recruitment,
hiring, training, promotion or any other employment practices for
reasons of race, color, religion, gender, national origin, age,
sexual orientation, marital or veteran status, disability, or any
other legally protected status. Intellia will make reasonable
accommodations for qualified individuals with known disabilities,
in accordance with applicable law. EEOC Statement: Intellia believes in a diverse environment, and
is committed to equal employment opportunity for all its employees
and qualified applicants. We do not discriminate in recruitment,
hiring, training, promotion or any other employment practices for
reasons of race, color, religion, gender, national origin, age,
sexual orientation, marital or veteran status, disability, or any
other legally protected status. Intellia will make reasonable
accommodations for qualified individuals with known disabilities,
in accordance with applicable law.
Keywords: Intellia Therapeutics, Cambridge , Regulatory Affairs Manager- CMC, Other , Cambridge, Massachusetts
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