Vice President, Head of Global CMC Regulatory Affairs
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:
Reporting to the Senior Vice President Regulatory Affairs, you will be responsible for the development and submission of regulatory filings for CRISPR/Cas9- based gene therapy projects, in the US and internationally. You 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 role will also focus on the mentoring, growth, and development of the regulatory staff. You will create a positive and supportive culture where transparency, a sense of urgency, delivering results, integrity and personal accountability are valued. In this role, you will maintain strong, collaborative relationships with all cross-functional leaders and strive to consistently support our vision of bringing to market therapies that provide clear benefits and improve patients’ lives.
- Additional role responsibilities include: Provide regulatory CMC strategic leadership to support development of multiple innovative 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 Japan
- 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
- Partner and work very closely with CMC, Analytical and Formulation 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
- Develops a growing regulatory organization and supervises regulatory professionals
- Contributes substantially as a leader on the Intellia Senior Leadership Team
We are looking to hire an experienced Regulatory Affairs leader, with a minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in CMC-focused Regulatory Affairs for biologics. A Master’s degree in life sciences in biochemistry, chemistry, biology, or related pharmaceutical fields including biochemical engineering is required and a PhD is preferred. If you describe yourself as solution oriented, independently motivated person, who enjoys working in a fast-paced, start up environment, we encourage you to apply! Additional role requirements include:
• Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
Excellent written and communication skills, strong technical knowledge, including CMC-regulatory writing
• Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc
• Detail oriented; science-based reasoning skills
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Travel Requirements: 10%
Meet your future team:
The Global Regulatory Affairs Department is undergoing rapid growth in response to an ever-increasing clinical development portfolio. The department is organized in three main components: Strategy, CMC, and Project Management/Operations. We are recruiting experienced regulatory professionals who thrive working on dynamic programs on collaborative teams. Communication, teamwork, and leadership are key to success on this highly collaborative team.
Currently, we have team members in both hybrid and remote capacities, so we will not require you to be local to our Cambridge, MA office. Although in a partially virtual environment, the team has made it a priority to continue to foster a sense of community among the group. You can expect to join a passionate, hardworking, and 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.