Regulatory Affairs Associate - 12 month contract (BBBH35036) Macquarie Park, Sydney, Australia
Benefits
- Exposure to working on regulatory submissions for prescription medicines
- Exposure to a variety of therapy areas. Mainly focusing on the lipid portfolio
- 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
Join the team on a 12-month contract role. 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.