Intellia Therapeutics

Associate Director, Regulatory Affairs CMC

Location
Cambridge, MA
Posted
Jun 25, 2022
Ref
R699
Required Education
Masters Degree/MBA
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 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:

You will serve as the Global Regulatory CMC Program and support development of one or more innovative cell-based gene therapy products for the treatment of severe genetic diseases. As a member of project teams, you will provide strategic CMC regulatory support to communicate risks and key issues in an evolving regulatory landscape for multiple innovativeprograms. You will also help define CMC content requirements for the quality sections of the regulatory dossier (IND/CTA and MF). Other responsibilities will include:

  • Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW

  • Support negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections

  • Drive adherence to CMC 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

  • Support development of manufacturing strategies for Intellia’s therapeutics, including assessing proposed manufacturing process changes and provide strategic regulatory guidance

  • Support the development of regulatory processes and standards

  • Partner and work very closely with CMC, Analytical Development, Supply Chain, Quality, Nonclinical, Clinical and Regulatory to ensure achievement of submission deadlines and obtain timely approvals of CMC‑related applications

  • Lead regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to CMC teams and Project teams

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 a Master’s degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields and a minimum 8 years of relevant biopharmaceutical industry experience, with at least 6 years' experience in CMC-focused Regulatory Affairs for biologics

  • Experience working with cell therapy, gene therapy products or mRNA-based therapeutics
  • Experience with non-viral or viral vectors
  • Supported interactions with regulatory health authorities and experience with submitting CTA/IND and BLA/MAA filings, ideally in an area related to gene therapy
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines

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 enjoys 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.

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.