Senior Regulatory Submission Specialist

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

📋 Description

• Execute all regulatory submission tasks in accordance with study specifications, ICON protocols, relevant regulations, and contractual deadlines.

• Create, modify, organize, and compile high-quality submission documents for Regulatory Agencies (RA), Central Ethics Committees (CEC), and other authorities.

• Assist in planning submission strategies, including the proactive identification and mitigation of risks.

• Engage directly with regulatory and ethics organizations as necessary.

• Oversee the complete lifecycle of submissions until approval is granted.

• Monitor submission progress and maintain thorough, accurate records in CTMS, eTMF, and other pertinent systems.

• Manage translation needs in line with project requirements.

• Identify out-of-scope tasks and aid in maintaining budget compliance.

• Keep project teams updated on all significant regulatory milestones and approvals.

• Collaborate with regional and global colleagues to achieve study objectives.

• Assist in the collection and upkeep of global/regional/country regulatory intelligence.

• Participate in process improvement initiatives that enhance workflows and add value.

• Guide junior team members and engage in system/procedure reviews based on experience.

• Complete all study-specific training promptly and adhere to ICON’s quality and compliance standards.

• Undertake any additional responsibilities necessary to support ICON’s success.

⛳️ Requirements

• At least 3 years of relevant regulatory experience in a CRO or pharmaceutical organization.

• Strong working knowledge of ICH-GCP, regional regulatory standards, ethics committee procedures, and clinical trial legislation.

• Exceptional organizational skills with an aptitude for managing competing priorities.

• A proactive, solutions-oriented mindset with a focus on continuous improvement.

• Excellent communication and stakeholder engagement abilities.

• A sincere commitment to delivering high-quality work and fostering team success.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options tailored to you and your family’s needs.

• Competitive retirement planning options to maximize savings and ensure confidence for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting your and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.