Senior Regulatory Affairs Specialist-Australia
Core
Lead regulatory activities for clinical trial startup and oversee global/multinational complex large clinical trial submissions.
Role type
Senior Regulatory Affairs Specialist (Clinical Trials)
Builds
Regulatory submissions (RA/EC) and country packages for clinical trials
Domain
Pharmaceutical/Biotechnology Clinical Trials
Required skills
Clinical regulatory affairs, IRB/IEC package preparation, Clinical Trial Applications (CTA), Global regulatory guidelines, EU-CTR process, Country-specific labelling, Regulatory review of essential documents (via careerplan.io/jobs/15-003-4E-077-senior-regulatory-affairs-specialist-australia-at-indero)
Preferred skills
Regulatory Affairs background, Additional languages, Regulatory Country Intelligence
Technologies
None stated
Responsibilities
Coordinate regulatory timelines and deadlines for RA and EC submissions; Address Sponsor queries regarding regulatory requirements; Provide local submission strategy and technical expertise; Prepare/review core and country packages for submission; Perform regulatory review of essential documents and authorize release; Develop/reviews Country ICFs and country-specific labelling content; Mentor new or junior colleagues; Support Regulatory Country Intelligence activities
Seniority
Senior, hands-on IC with mentorship
