Senior Regulatory Affairs Specialist
Core
Completing country and/or regional Clinical Trial Regulatory deliverables (DDCM and DEEC) according to study specifics, ICON policies, and ICH-GCP principles.
Role type
Senior Regulatory Affairs Specialist
Builds
Clinical trial submission documentation and regulatory intelligence for country-level bodies
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Clinical trial submissions, regulatory agency requirements, submission pack preparation, translation management, CTMS/eTMF data entry, risk mitigation, budget adherence
Preferred skills
Staff training/mentoring, review of ICON systems and procedures
Technologies
CTMS, eTMF
Responsibilities
Input to strategic planning of submissions to RA (DDCM and DEEC) and other country-level bodies; Direct interaction with regulatory authorities (mainly ANVISA); Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation; Arrange internal/external review of submission/documentation; Track and file central submission/approval progress in CTMS and eTMF; Perform translation management; Support surveillance, collection, and maintenance of accurate clinical trial global/regional/country and regulatory clinical trial intelligence
Seniority
Senior, hands-on IC