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Associate Director, Regulatory Affairs

Employer
Intellia Therapeutics
Location
Cambridge, MA
Start date
Aug 10, 2022

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Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

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 wantall ofour 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:

We are excited to welcome this new member to our growing team and company. This is both a strategic and hands-on role. If you are an independently motivated and results-oriented person who enjoys collaborative team-oriented environments where results are achieved through influence and the incorporation of multiple points of view, this is the role for you! As the Associate Director, Regulatory Affairs you will:

  • May lead Global Regulatory Team on designated programor project

  • Drive development of regulatory strategy to enable initiation of clinical development and clarify path to registration for novel gene therapies

  • Interpret regulations, policies, and guidelines and advise cross-functional teams on regulatory requirements to support development

  • Lead the planning, preparation (including authoring where relevant) and execution of regulatory submissions for assigned programs

  • Represent regulatory on the program team and present to company committees as needed

  • Serve as a liaison within internal departments at Intellia, with CROs, and with regulatory personnel at the various Health Authorities

  • Keep abreast of changing regulations, guidance documents, and relevant technical/scientific developments

  • Support other projects as assigned

About You:

For this role, you will need to have a Bachelor's degree in Biology, Chemistry, or other related discipline. A relevant master’s degree or other advanced degree is preferred. Typically requires 6-8 years relevant pharmaceutical or biotech industry experience within regulatory affairs or equivalent in education and experience. Understanding and/or experience in ATMP field is desired or preferred. Ideally, your experience would include gene or cell-based therapeutics, RNA-based therapeutics, and/or orphan drug development. Mastery of regulatory requirements for drug development is required as well as exposure to interactions with global regulatory health authorities (eg FDA, EMA) and different submission types. Excellent written and verbal communication skills, including regulatory writing, are essential. To be successful in this role, you will need to have confidence in your leadership skills to represent the regulatory function in cross-functional teams and be able to think strategically as well as tactically.

Meet your future team:

The Global Regulatory Affairs group is a rapidly growing and valued team within Intellia and is comprised of respected professionals with diverse regulatory expertise in both large pharma and small biotech settings. You will report to the Director/Sr. Director, Global Regulatory Affairs. The team leads all regulatory strategy development and implementation for Intellia’s in vivo and ex vivo development candidates and the rich pipeline products in research. The regulatory team is currently working virtually. We do have plans to return to the Cambridge MA office in a hybrid remote-onsite model, tentatively scheduled for January 2022. Although in a virtual environment, the Regulatory Affairs team has made it a priority to continue to foster a sense of community among the group. You can expect to join a hardworking, collaborative environment.

#LI-KD1

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

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.

Company

Many of us pursuing work in the biotechnology industry are inspired by a loved one who is living with a disease or the loss of someone in our community. Rare genetic and oncological and immunological diseases not only affect the people living with often debilitating and life-threatening symptoms, but these disorders also significantly impact their families, friends and caregivers.
 
Our researchers work tirelessly to harness the genome editing technology CRISPR/Cas9 for human therapeutic use. Jennifer Doudna, an Intellia co-founder, and Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. We at Intellia are humbled to have a hand in making what we believe to be medical history. As a leader in this space, we take this responsibility to patients seriously.
 
We are employing a modular genome editing platform to create diverse in vivo and ex vivo pipelines, spanning a range of therapeutic indications. Guided by this full-spectrum approach, we are committed to making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.

Change life stories with genome editing therapies!

Stock Symbol: NTLA

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Find Us
Website
Phone
(857) 285-6200
Location
40 Erie Street
Cambridge
Massachusetts
02139
United States
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