Associate Director of Global Regulatory Operations
Company: EQRx, Inc.
Location: Cambridge
Posted on: April 5, 2021
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Job Description:
Associate Director of Global Regulatory Operations 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 As Associate
Director Regulatory Operations, you will play a key role in our
highly dynamic organization. You will oversee the end-to-end
submission execution activities including, planning/scheduling,
publishing, QC and dispatch/transmit our regulatory submissions to
health authorities per guidance. You will participate in the
building of a Best in Class Regulatory Operations team. You will
work closely with your Regulatory and cross-functional colleagues
and provide vendor management oversight to ensure compliance to our
submission standards. You will serve as the Business Owner for the
publishing system, which includes active participation in
publishing system maintenance and backup activities by partnering
with the Informatics team for system validation and establishing
system specific business requirements. This role will be
responsible for the development of country specific submission
requirements manuals and maintenance based on industry and country
requirement changes. To support these efforts, you will need to
monitor changes in regulations and guidelines for submission
publishing impact, participate in industry engagements, disseminate
relevant changes in regulations and guidance to affected parties
and design and direct implementation of training as required to
support changes. You will serve as an SME (subject matter expert)
to submission filing teams to ensure filing excellence. You will
develop global strategic plans to support current and future health
authorities' submission requirements to apply consistency for all
EQRx submission publishing standards and processes. You will also
assist in developing, implementing, and communicating the Global
Regulatory Operations vision, metrics, budget activities, core
capabilities, process improvements and value while championing a
strong Submission Excellence Culture. The Impact You Will Have This
is not your standard Regulatory Operations position. We are doing
things different here than how it is normally done, and this role
is no exception. This position is highly visible and of significant
impact to the company. We are on a critical mission to bring
quality solutions to patients at a fraction of the price. This role
will help us drive forward towards that pinnacle goal of truly
putting patients first. Your Superpowers -- You have a bachelor's
or master's degree. -- You have significant
pharmaceutical/biotechnology industry experience, with a minimum of
5+ years within Regulatory Operations. -- You have a thorough
understanding of process and technology solutions. -- You have 5+
years of hands-on experience with a variety of regulatory e/CTD
submission dossiers from clinical development through
commercialization (IND, IMPD, CTA, NDA, NDS, BLA, MAA), briefing
documents, agency queries and responses, and other submission
dossier types. -- You have knowledge and experience with electronic
content/document management systems, preferably Vault RIM, eCTD
publishing tools, and publishing systems. -- You are knowledgeable
of pharmaceutical regulations including, ICH guidance, GxP, and
good -- You possess strong communication, organizational and
presentation skills. -- You can participate and work effectively on
multiple cross-functional teams. -- You understand relationships
are key and have strong interpersonal skills. -- You are a leader.
Teams love working with you and you are someone who takes pride in
mentoring and supporting the careers of others. -- You can thrive
in a smaller company environment and love the pace of a true
startup. -- You're a team player who is willing to roll-up your
sleeves and get the job done. Are you bold enough? Your work should
matter and allow you the freedom to be 100% you. We spend too much
time and effort in our career to not feel excited and proud about
what we do and who we do it with.--In other words, your career is
too important for your next move to be just another job, so let's
work together to change the world and bring affordable medicines to
all patients. We aren't about a bunch of empty slogans on a wall or
words on a coffee cup - you can find that in lots of places. We are
a culture of individuals with diverse backgrounds and
personalities. What does EQRx stand for?-- EQ uality Medicines:
Equally good or better, innovative medicines EQ uitable Medicines:
Making innovative medicines affordable EQ ual Access: Sustainable,
frictionless access for people to cutting-edge medicines We have a
bold mission and are looking for equally bold people who want to
join us and help make a difference in the world. If you want to
grease the wheel we are definitely not for you. Want to build the
wheel? We might be just what you are looking for. Your work should
matter and allow you the freedom to be 100% you. We spend too much
time and effort in our career to not feel excited and proud about
what we do and who we do it with. In other words, your career is
too important for your next move to be just another job, so let's
work together to change the world and bring affordable medicines to
all patients. We aren't about a bunch of empty slogans on a wall or
words on a coffee cup - you can find that in lots of places. We are
a culture of individuals with diverse backgrounds and
personalities. The Dreamer Are you ready to think differently and
embrace the journey?
SuperpowerWhat's yours? Find the right job for your skills. Stay in
the Loop Get Job Alerts Follow on social. Stay connected on
Glassdoor, Instagram, Twitter & LinkedIn!
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 , Associate Director of Global Regulatory Operations, Executive , Cambridge, Massachusetts
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