Kyverna - Manager of Regulatory Affairs, Consultant

Remote - USA *1w ago

Remote Mid NA Pharmaceuticals Biotechnology Regulatory Affairs Manager Regulatory Affairs Documentation Team Management Reporting Quality Assurance Cross-functional Collaboration Regulatory Compliance

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. • 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.

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: • Manage the preparation, review, and submission of all components of regulatory submissions including INDs/CTAs and amendments, BLAs, annual reports, safety reports, etc. • Prepare and coordinate company responses to queries from health authorities. • Ensure regulatory documents are compliant with global regulatory requirements and guidelines. • Quality and Compliance: • Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations 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. • Serve as Regulatory lead for study-level management teams. • Regulatory Intelligence: • Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.