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 IC regulatory affairs specialist (clinical trials)
Builds
Clinical trial applications and regulatory packages for pharmaceutical/biotech clients
Domain
Pharmaceutical/Biotechnology / Clinical Research
Required skills
Clinical regulatory affairs expertise, Global regulatory requirements knowledge, EU-CTR process experience, IRB/IEC package preparation, Country-specific submission strategy, Labelling content development, Essential document review, Mentorship (via careerplan.io/jobs/15-003-4E-077-senior-regulatory-affairs-specialist-australia)
Preferred skills
Regulatory Affairs background, Additional languages
Technologies
None stated
Responsibilities
Coordinate regulatory timelines and deadlines for RA and EC submissions, Address Sponsor queries regarding regulatory requirements, Prepare and review core packages for submission, Perform regulatory review of essential documents, Develop and review country-specific labelling content, Act as a mentor to junior colleagues
Seniority
Senior, hands-on IC
