Regulatory Affairs Specialist

Job Description

As a Regulatory Affairs Specialist, you will play a critical role in ensuring our products meet all regulatory requirements. Your responsibilities will include developing regulatory strategies, preparing submissions, and collaborating with cross-functional teams to ensure compliance.

Responsibilities

• Communicate regulatory issues to stakeholders effectively.
• Maintain up-to-date knowledge of regulatory affairs and industry standards.
• Review and approve promotional materials for compliance.
• Support risk assessment related to regulatory impacts.
• Contribute to the development of regulatory policies and procedures.
• Monitor product performance post-launch to ensure ongoing compliance.
• Assist in the development of product development strategies influenced by regulatory concerns.
• Ensure the compliance of clinical trial submissions and reports.
• Work closely with marketing, research, and development teams to align strategies.
• Manage multiple projects while maintaining attention to detail and deadlines.

Requirements

Education

• Bachelor’s degree in a relevant scientific discipline
• Master’s degree is a plus

Experience

• 5+ years of relevant experience in a regulatory role within biotech or pharmaceuticals

Technical Skills

• Knowledge of FDA and TGA regulations
• Analytical Skills

Soft Skills

• Problem-solving Skills
• Team Player

Certifications

• Certified Regulatory Affairs Specialist (CRAS)
• Lean Six Sigma Certification

Languages

• English: Fluent

Advantageous

• Knowledge of clinical trial regulations: Understanding of regulations governing clinical trials in Australia.
• Project Management experience: Hands-on experience managing compliance projects within the pharmaceutical sector.

Benefits

• Comprehensive health insurance
• Bonus structure based on performance
• Support for continuous learning and development
• Work-life balance initiatives

Company Culture

• Continuous Improvement: We foster a culture of continuous improvement to enhance our processes and employee satisfaction.
• Respect and Integrity: We uphold the highest standards of respect and integrity in all our interactions.
• Fun and Supportive Environment: We aim to create a workplace where everyone enjoys their work and supports one another.