Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Australia.

📋 Description

• Lead projects related to regulatory activities that facilitate the startup of clinical trials.

• Manage submissions for large, complex clinical trials on a global and multinational scale.

• Provide regulatory leadership to sponsors and oversee regulatory deliverables within a specific country, region, or globally.

• Assist the Associate Director of Regulatory Affairs with special projects, initiatives for process improvement, employee training, and company objectives.

• Coordinate regulatory timelines and deadlines for submissions to Regulatory Authorities (RA) and Ethics Committees (EC).

• Spearhead global and multinational submissions for large, complex clinical trials.

• Respond to sponsor inquiries regarding regulatory and submission requirements.

• Offer regulatory support, guidance, local submission strategies, and technical expertise to project teams.

• Prepare and review core and country-specific submission packages, which include initial applications, amendment packages, and notifications.

• Conduct peer reviews of documents and packages created by regulatory colleagues.

• Develop and evaluate Country Informed Consent Forms (ICFs).

• Review essential documents and authorize regulatory release prior to the shipment of investigational products to clinical sites.

• Create and assess country-specific clinical trial drug labeling.

• Participate in kick-off meetings, client audits, and project-related discussions.

• Mentor new or junior regulatory colleagues, including task assignment, coaching, training, and the development of tools and processes.

• Support activities related to Regulatory Country Intelligence.

⛳️ Requirements

• A Bachelor's degree (or equivalent) in a scientific discipline; a background in Regulatory Affairs is advantageous.

• 3–5 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, and/or CRO sectors.

• Proven experience in preparing and submitting Institutional Review Board (IRB)/Independent Ethics Committee (IEC) packages and/or Clinical Trial Applications.

• Strong comprehension of global regulatory requirements and guidelines pertinent to assigned countries/regions.

• Background in a global leadership position with a focus on the regulatory landscapes of Europe and APAC, including Australia/New Zealand.

• Familiarity with the regulatory process under the EU Clinical Trials Regulation (EU-CTR).

• Proficiency in English, with excellent oral and written communication skills is essential.

• Knowledge of additional languages is a valuable asset.

• High attention to detail and accuracy in all tasks.

• Ability to manage personal workload, prioritize various assignments, and perform under pressure.

• Adaptable and comfortable working in a multitasking environment.

• Capability to adhere to established timelines, expectations, priorities, and objectives.

• Must have legal authorization to work in Australia.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time employment.

• Comprehensive benefits package (including medical, dental, vision, RRSP, vacation, personal days, access to a virtual medical clinic, public transportation rebates, and social activities).

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.