Regulatory Affair Manager
Core
Lead regulatory strategy and operational support for prescription medicines from development through post-marketing, ensuring compliance with global health authority requirements.
Role type
Senior IC Regulatory Affairs Manager
Builds
Global and regional regulatory submissions, briefing materials, and responses to health authorities
Domain
Biopharmaceuticals / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global/regional drug regulatory approval process knowledge, submission standards, project management, cross-functional team leadership, risk mitigation, document management technology
Preferred skills
Line or matrix management, resource planning for pivotal projects, deep understanding of evolving industry trends
Technologies
Electronic and paper submission tools
Responsibilities
Plan and deliver complex regulatory submissions, advise senior management on regulatory strategies and risks, drive continuous improvement in submission processes, build partnerships with internal and external partners, mentor colleagues, interpret changing health authority requirements, champion new regulatory systems
Seniority
Senior, hands-on IC with mentorship responsibilities
