Regulatory Affairs Manager – Respiratory and Immunology
Core
Lead end-to-end planning, coordination, and execution of regulatory submissions (CTA/IND) for clinical trials in Respiratory and Immunology therapies.
Role type
Senior IC Regulatory Affairs Manager
Builds
Regulatory submissions for clinical trial applications and investigational new drug submissions
Domain
Biopharmaceuticals, Respiratory and Immunology
Required skills
Regulatory framework knowledge, CTA/IND submission experience, project management, leadership, risk identification, cross-functional coordination, document review, process improvement
Preferred skills
Health authority experience, drug development knowledge, digital tools proficiency
Technologies
Trial Master File management systems, digital submission tools
Responsibilities
Understand regional regulatory requirements for clinical trial applications; Provide regulatory input on documentation requirements; Lead planning and delivery of CTA/IND submissions; Coordinate cross-functional contributions for complete and inspection-ready submissions; Review study protocols and safety-related documents; Identify regulatory risks and propose mitigations; Support compliance activities and document management; Mentor team members; Contribute to process simplification and standardization
Seniority
Senior, hands-on IC