Director Regulatory Affairs CMC

Location
Cambridge, MA, United States
Posted
Feb 06, 2021
Ref
R15
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

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.

Job Description:

Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

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.

Summary:

A career within Intellia's lean, fast paced regulatory team will give you the opportunity to grow your experience quickly and to be involved in the most exciting area in gene and cell therapy by advancing the application of CRISPR/Cas9 genome editing technology. Working with an experienced team of regulator professionals, each role within the Regulatory team is highly visible and has a direct impact on bringing Intellia's therapeutics to patients quickly.

Reporting to the Vice President, Regulatory Affairs, the Director of Regulatory CMC will be responsible for the development and submission of regulatory filings for CRISPR/Cas9- based gene therapy projects, in the US and internationally. The individual will drive the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs), in close collaboration with analytical, CMC and Quality teams, contract manufacturing organizations, and external consultants and collaborators.

This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range disciplines with diverse regulatory requirements from gene and cell therapy guidances, to vaccines related guidance's to DNA therapeutic guidances and oligonucleotide in an evolving regulatory landscape.

Responsibilities:
  • Provide regulatory CMC strategic leadership to support development of multiple innovative cell-based gene therapy products for the treatment of severe genetic diseases
  • As a member of project teams, provide strategic CMC regulatory leadership support for multiple innovative programs
  • 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
  • Lead 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, 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


Qualifications:
  • Master's degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree, such as a PhD is desirable
  • Minimum 10 years of relevant biopharmaceutical industry experience, with at least 8 years' experience in CMC-focused Regulatory Affairs for biologics
  • Experience working with cell therapy, gene therapy products or mRNA-based therapeutics
  • Experience with Orphan Drug Designation, BTD, RMAT, a plus
  • Experience with non-viral or viral vectors
  • Direct 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
  • Travel Requirements: 10%


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.