Regulatory Manager / Senior Regulatory Manager
Core
Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures to ensure timely preparation of quality regulatory submissions.
Role type
Senior IC Regulatory Manager (Clinical Development)
Builds
Regulatory submissions (IND/CTA, annual reports, marketing applications) and strategic regulatory input for oncology and rare disease therapies.
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory strategy, Clinical submission management, ICH GCP guidance, Regional regulatory knowledge (EU/US), Project coordination, Team leadership, Drug development lifecycle knowledge, Protocol interpretation, Quality initiatives execution, Financial management basics
Preferred skills
Experience in CRO or Pharmaceutical Industry, Leading clinical submissions, Training internal/external clients, Business development participation, Process improvement
Technologies
Regulatory intelligence tools, Project trackers
Responsibilities
Compile and review applications to Regulatory Authorities (CTA/IND, amendments, orphan designations, paediatric planning); Develop and review documents for submission; Serve as representative of Global Regulatory Affairs at project and business development meetings; Oversee and coordinate Regulatory Affairs Specialists; Maintain project plans and trackers; Provide ICH GCP guidance and training; Assist in developing staff and establishing company standards.
Seniority
Senior, hands-on IC with leadership responsibilities