Regulatory Affairs Manager- CMC

Location
Cambridge, MA, United States
Posted
Jul 20, 2021
Ref
R227
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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
  • Maintaining an up-to-date awareness of CMC regulatory requirements for applicable territories and communicating key intelligence to the organization in a timely manner.


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.

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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.