Senior Manager, Regulatory Affairs
Emeryville, CA
Regulatory Affairs /
On-site
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Kyverna is seeking an experienced and driven Manager/Senior Manager of Regulatory Affairs to join our regulatory team. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.
Responsibilities:
- Regulatory Strategy:
- Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines.
- Assist in planning and coordinating regulatory submissions and interactions with health authorities.
- Regulatory Submissions:
- Prepare, review, compile, and archive regulatory submissions and correspondence, including Investigational New Drug (IND) applications, Biological License Applications (BLA), Regenerative Medicine for Advanced Therapy (RMAT) Applications, Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), Orphan Drug Designation (ODD) Applications, Pediatric Investigational Plans (PIP), Suspected Unexpected Serious Adverse Reaction (SUSAR) submissions, Development Safety Update Report (DSUR) submissions, and other submissions as necessary.
- Ensure regulatory documents are compliant with global regulatory requirements and guidelines.
- Regulatory Expertise:
- Leverage regulatory knowledge to provide guidance and insights to support regulatory strategies.
- Stay informed about evolving regulatory requirements, industry trends, and best practices.
- Quality and Compliance:
- Collaborate with Quality Assurance and Regulatory teams to ensure adherence to Good Manufacturing Practices (GMP) and regulatory compliance.
- Support regulatory inspections and audits as needed.
- Cross-Functional Collaboration:
- Collaborate with cross-functional teams, including Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments, to align regulatory strategies with organizational goals.
- Regulatory Intelligence:
- Stay updated on evolving regulatory requirements and guidelines relevant to our therapies.
- Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.
Requirements:
- Bachelor's or advanced degree in a relevant scientific field.
- Minimum of 2-5 years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.
- Highly experienced in EU clinical trial applications
- Proficiency in global regulatory requirements and guidelines.
- Experience in preparing regulatory submissions, including INDs, and MAAs.
- High attention to detail, very strong organizational skills, and project management capabilities.
- Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
- Ability to adapt to a dynamic regulatory environment.
$165,000 - $195,000 a year
The salary range for this position is from $165,000 - $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, experience, tenure, skills and abilities, 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
