Senior Regulatory Affairs Specialist-Australia

Description The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally. This role will also support the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees and company initiatives. RESPONSABILITIES Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Lead global/multinational submissions of complex large clinical trials. Addresses Sponsor queries related to regulatory and submission requirements. Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise. Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance. Peer review of documents and packages prepared by colleagues within regulatory team. Develops/reviews Country ICFs. Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites. Develops/reviews country-specific labelling content for clinical