Regulatory Affairs Associate

Benefits

This role offers exposure to working on regulatory submissions for prescription medicines. With exposure to a variety of therapy areas. Join a global organisation with a strong product pipeline, with the support of a large regulatory team

About the company

Our client is a large global pharmaceutical company based in Macquarie Park. The company are passionate about team and culture fit. They have an exciting pipeline of products and work across multiple therapeutic areas

About the opportunity

Working within the regulatory team your main responsibility will be to ensure regulatory compliance of the prescription product portfolios. You will work closely with the quality and marketing teams to provide technical guidance and support

Duties

• Dossier preparation and submissions - Cat 1 and Cat 3 applications
• Maintenance of product registrations
• Artwork approvals, product information updates
• Liaise with TGA and internal colleagues
• Provide technical support to quality and marketing teams

Skills and Experience

• Minimum 2 years regulatory affairs experience in pharmaceutical industry
• Knowledge of Australian regulatory requirements and guidelines
• Tertiary qualification desirable in Pharmacy, Pharmacology or relevant science subject
• Strong relationship with the TGA and or Medsafe
• Ability to work cross functionally
• Excellent team player, proactive and competent
• Effective verbal and written communication

Culture

Strong work ethic, determined, dedicated, and driven to achieve targets. Transparent and honest working together to meet common goals. Cross functional environment, working collaboratively across the business

How to Apply

Click apply or contact Davina Ocansey, Sourcing Consultant on +61 2 8877 8712 for a confidential discussion.