(Sr) Director, Global Regulatory Strategy

Location
Cambridge, MA, United States
Posted
Feb 09, 2021
Ref
R73
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
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.

Title: (Sr) Director, Global Regulatory Strategy

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:

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 (Sr) Director, Global Regulatory Strategy you will work on various projects including:

  • Leading global regulatory strategy for Intellia's in vivo therapeutic platform which includes multiple, innovative gene therapy products for the treatment of severe genetic diseases.
  • Understanding and interpreting complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provides knowledge and expertise to guide team in appropriate regulatory strategy.
  • Managing and implementing planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US, EU, Japan, and ROW.
  • Assuming direct point of contact with health authorities, lead and manage FDA/global health authority interactions/meetings for project responsibilities; prepare and submit responses to queries.
  • Driving adherence to global regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals.
  • Partnering very closely with Nonclinical, Tech Ops, Quality and Clinical groups to ensure achievement of submission deadlines and obtain timely approvals of clinical trial applications.


You will have a PhD degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering, with a minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' biologics experience in Regulatory Affairs. Ideally, your experience would include gene or cell-based therapeutics, RNA-based therapeutics and/or orphan drug development. Expertise with drug development across all phases of clinical development is required as well as deep experience with global regulatory health authorities (eg FDA, EMA) and different submission types. Excellent written and verbal communication skills, including regulatory writing, are essential. You will have strong leadership qualities including strategic thinking, innovation, mentoring and collaboration.

Meet your future team:

The Regulatory Affairs group is a rapidly growing team within Intellia and includes professionals with diverse regulatory expertise in both large pharma and small biotech settings. You will report to the Vice President, Regulatory Affairs, and will manage a RA Manager. The team leads all regulatory strategy and implementation for Intellia's in vivo and ex vivo development candidates and the rich pipeline products in research.

The team is currently working virtually. While we do have plans to return into the Cambridge MA office, tentatively we are scheduled to return in June 2021. 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.

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.