Regulatory Affairs Specialist

Job Description

We are seeking a passionate Regulatory Affairs Specialist to join our team in Sydney. You will be instrumental in ensuring that healthcare products comply with regulatory requirements throughout their lifecycle. The ideal candidate will possess strong analytical skills and a thorough understanding of regulatory processes.

Responsibilities

• Coordinate with external consultants and regulatory agencies to facilitate communication and workflow.
• Prepare responses to regulatory inquiries and ensure timely resolution.
• Conduct internal audits to ensure adherence to regulatory standards.
• Reporting and tracking of compliance metrics.
• Participate in regulatory inspections and audits.

Requirements

Education

• Bachelor's degree in Pharmacy or a related field
• Master's degree in Regulatory Affairs is advantageous

Experience

• 4+ years of experience in regulatory affairs, with a focus on medical devices or pharmaceuticals

Technical Skills

• Compliance Strategy
• Data Analysis

Soft Skills

• Problem-solving
• Team Leadership

Certifications

• Certified Regulatory Affairs Specialist (CRAS)
• Project Management Professional (PMP)

Languages

• English: Fluent

Advantageous

• Experience in clinical trials: Demonstrated experience in regulatory affairs associated with clinical trial management.
• Understanding of risk management: Knowledge in assessing and mitigating risks related to healthcare products.

Benefits

• Comprehensive health coverage including dental and vision
• Annual performance-based bonuses
• Continuing education allowances
• Work-life balance initiatives

Company Culture

• Innovation: We are committed to innovation and encourage our team to think creatively and challenge the status quo.
• Continuous Improvement: We believe in continuous improvement and professional growth for all employees.
• Responsiveness: Our team is responsive and adaptive to the changes in industry standards and regulations.