Regulatory Affairs Manager

Job Description

As a Regulatory Affairs Manager, you will be pivotal in developing and implementing regulatory strategies to ensure compliance with all relevant laws and regulations. We are looking for a proactive leader who can manage cross-functional teams and guide our organisation through the regulatory landscape.

Responsibilities

• Lead the regulatory team to achieve compliance with TGA, FDA, and EMA regulations.
• Collaborate with departments to ensure product registration and compliance with relevant regulations and guidelines.
• Provide leadership and oversight in regulatory submissions such as INDs and NDAs.
• Interact with regulatory authorities to resolve regulatory issues.
• Analyze changes in the regulatory environment and provide recommendations to senior management.
• Develop and maintain effective relationships with regulatory authorities and industry associations.

Requirements

Education

• Bachelor’s degree in a related field
• Advanced degree in Regulatory Affairs is an advantage

Experience

• At least 10 years of regulatory experience in the pharmaceuticals sector

Technical Skills

• Electronic Document Management Systems (EDMS)
• Microsoft Office Suite

Soft Skills

• Project management skills
• Ability to manage multiple projects simultaneously

Certifications

• Certified Regulatory Affairs Specialist (CRAS)

Languages

• English: Fluent

Advantageous

• Experience working with cross-functional teams in a global environment: Proven ability to foster collaboration across diverse teams.

Benefits

• Generous leave entitlements
• Wellness programs and initiatives
• Access to industry conferences and training
• Collaborative and inclusive workplace culture

Company Culture

• Continuous Learning: We support ongoing training and professional development for our employees.
• Employee Well-being: We care about our employees’ well-being and provide resources to support mental and physical health.