Associate Director, CMC Regulatory Affairs
Emeryville, CA /
Regulatory Affairs /
Full Time
/ On-site
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Kyverna is navigating what’s next in the synthetic biology, immunology and cell engineering to create a new class of T-cell therapies programmed to target and selectively modulate the underlying causes of autoimmunity. Join the front lines of a cell therapy revolution where scientists, industry veterans and healthcare visionaries are creating a new class of living medicines for autoimmune disease.
Kyverna is recruiting an Associate Director CMC Regulatory Affairs in its Regulatory Affairs and Quality organization to help advance its mission to transform the treatment of autoimmunity for the benefit of patients. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.
Responsibilities:
- Reporting to the VP, Regulatory Affairs and Quality
- Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Cell and Gene Therapy projects/products.
- In close collaboration with Technical Operations and Program teams, lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- In collaboration with Technical Operations and Program Teams, proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
- Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions.
- Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated Regulatory Notifications
- Initiate and lead Health Authority interactions and negotiations related to CMC topics.
Requirements:
- Bachelor’s degree or equivalent experience in life science.
- Minimum 8 years of regulatory CMC experience and/or pharmaceutical industry experience with direct experience in Cell and Gene Therapies essential. Global Cell and Gene Therapy Regulatory experience preferred.
- Trained in and/or experienced with Cell and Gene Therapy CMC requirements, supplemented with Regulatory professional certifications desirable.
- Demonstrated knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
- Ability to manage complex CMC regulatory challenges and requirements while leading/working in interdisciplinary teams.
- Well-developed planning, organizational, negotiation, problem solving and interpersonal skills.
- Excellent verbal, written and presentation skills and effectively communicate with all levels of management.
- Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
- Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
- Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
- Self-starter, works effectively in cross-functional teams.
The base salary range for candidates residing in California for this position is $164,000 USD to $195,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, relevant experience, tenure, skills and abilities, geographic location, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
