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Associate Director, Regulatory Affairs

Company: Intellia Therapeutics
Location: Cambridge
Posted on: March 18, 2023

Job Description:

Associate Director, Regulatory Affairs page is loaded Associate Director, Regulatory Affairs Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R768 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 Associate Director, Global Regulatory Strategy you will:

  • Serve as the Global Regulatory Program Lead for one or more programs.
  • Drive the development of regulatory strategy to enable initiation of clinical development and clarify the 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 For this role, you will need to have a bachelor's degree in the life sciences, with a minimum of 6 years of experience in Regulatory Affairs strategy. 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.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. About Us At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Keywords: Intellia Therapeutics, Cambridge , Associate Director, Regulatory Affairs, Executive , Cambridge, Massachusetts

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