Senior Regulatory Affairs Specialist
Core
Prepare and manage clinical trial regulatory submissions (DDCM and DEEC) for country and regional authorities, ensuring compliance with ICH-GCP and local regulations.
Role type
Senior Regulatory Affairs Specialist (Clinical Trials)
Builds
Regulatory submission packages and documentation for clinical trials
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Clinical trial submission management, regulatory compliance (ICH-GCP), interaction with regulatory authorities, submission documentation preparation, translation management, project budget adherence, process improvement
Preferred skills
Mentoring junior staff, reviewing internal systems and procedures
Technologies
CTMS, eTMF
Responsibilities
Input to strategic planning of submissions to regulatory authorities; Direct interaction with regulatory authorities (e.g., ANVISA); Ensure timely preparation and coordination of submission packs; Arrange internal/external review of documentation; Track and file submission progress in CTMS and eTMF; Perform translation management; Support surveillance and maintenance of clinical trial intelligence
Seniority
Senior, hands-on IC