Senior Regulatory Affairs Specialist-Australia

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 trial drug supplies to ensure conformity with regional regulations requirements.

• Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs

• Act as a mentor to new or junior colleagues within regulatory team. Responsibilities could include helping in assigning work; coaching/training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory/ethics submissions

• Support Regulatory Country Intelligence activities

• Bachelors' degree (or equivalent) in a scientific discipline. Regulatory Affairs is an asset

• 3-5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and /or Clinical Trial Applications

• Strong understanding of global regulatory requirements and guidelines in assigned countries / regions.

• Experience in global leadership role with a focus on regulatory regions such as Europe and APAC (Australia/New Zealand). Experience of the regulatory process under EU-CTR.

• Fluency in English with excellent oral and written skills, required

• Additional languages represent an asset

• Attention to detail and accuracy in work

• Ability to organize own work, prioritize different assignments, and work under pressure

• Versatile and comfortable in a multitasking environment

• Respect established timelines, expectations, priorities, and objectives