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Posted: 10/20/2026Manager – Regulatory Affairs, Consultant
Kyverna TherapeuticsCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs with a strong focus on compliance with global regulatory requirements, including ICH guidelines. Proven ability to manage regulatory submissions and collaborate effectively across cross-functional teams in the biotechnology or pharmaceutical sector.
Highest-signal resume keywords
Regulatory Submissions ManagementKnowledge of ICH GuidelinesExperience with CTD/eCTDProject Management CapabilitiesEffective Communication Skills
About the role
Key responsibilities & impact- 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.
- Manage the preparation, review, and submission of regulatory submissions, including INDs/CTAs and amendments, BLAs, annual reports, and safety reports.
- Prepare and coordinate company responses to health authority queries.
- Ensure regulatory documents comply with global regulatory requirements and guidelines.
- Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance.
- Support regulatory inspections and audits as needed.
- Collaborate with Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments.
- Serve as Regulatory lead for study-level management teams.
- Assess changes in the regulatory environment and communicate their impact on product development strategy.
- Report to the Executive Director, Regulatory Affairs.
Requirements
What you’ll need- 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.
- Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.
- Experience with cell or gene therapy regulatory affairs.
- Experience with CTD/eCTD and life cycle management.
- High attention to detail, 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.
- West Coast hours preferred.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Strategy DevelopmentINDs/CTAs PreparationBLAs SubmissionSafety Reports ManagementRegulatory ComplianceGXP Regulations AdherenceCell or Gene Therapy Regulatory AffairsLife Cycle ManagementRegulatory Inspections SupportHealth Authority Interactions
Soft Skills
Attention to DetailOrganizational SkillsInterpersonal SkillsCollaboration SkillsAdaptability
Industry Keywords
BiotechnologyPharmaceutical SectorRegulatory AffairsGlobal Regulatory RequirementsRegulatory Environment TrendsCross-Functional CollaborationQuality AssuranceClinical OperationsTechnical DevelopmentRegulatory Compliance