Clinical Regulatory Officer

Overview

• Work for a full service CRO
• Manage regulatory and ethics submissions
• Permanent role

Benefits

• Market leading global CRO
• Inclusive team with development opportunities
• Hybrid work from home role
• Attractive salary package

About the company

Full service CRO that has an outstanding reputation for client success. This CRO works across multiple therapeutic areas and emphasizes the importance of meeting trial timelines, which ensures client satisfaction, repeat business and ultimately patient health and safety. Join an expanding global CRO that is adaptable, novel and has a client success rate of over 90%.

About the role

The regulatory officer will work on a dynamic team and assist in all regulatory and ethics submissions for the start-up of trials for some highly innovative medicines.

Duties

• Prepare clinical trial submission for Regulatory and Ethics Authorities for the ANZ region
• Work cross functionally with external and internal stakeholders within regulatory
• Manage translations of essential submission documents
• Manage the regulatory workflow and track documents
• Review documents for IP release
• Oversee safety reporting to applicable parties
• Train staff on regulatory matters where appropriate
• Contribute to feasibility and manage business development

Skills and Experience

• Degree in life sciences or equivalent
• 2-3 years' experience working in a pharmaceutical or CRO environment
• Experience in regulatory or ethics submissions (New Zealand submissions desirable)
• Experienced in TGA and Medsafe submissions
• Excellent understand of ICH-GCP guidelines
• Great communication skills and ability to work cross-functionally
• Full Australian working rights

Company Culture

The company prides itself on pushing the boundaries of clinical research in order ensure breakthrough research for patient's worldwide and by having a wide network of employees worldwide with this common goal in mind.

How to Apply

Click apply or for a confidential discussion contact:

Mattias Fitzgerald, Recruitment Consultant on +61 2 8877 8749; or

Davina Ocansey, Recruitment Consultant on +61 2 8877 8712