Regulatory Affairs Associate - 3 month contract (BBBH35132) Macquarie Park, Sydney, Australia
Benefits
- Work cross functionally in a supportive environment
- Exposure to a variety of therapy areas, including Women’s Health
- Join a global organisation with a strong product pipeline, with the support of a large regulatory team
About the company
A large global pharmaceutical company that have an exciting pipeline of products and work across multiple therapeutic areas. They are passionate about team and culture fit.
About the opportunity
Join the team on a 3-month project-based role supporting the regulatory activities of the team. You will be required to collaborate closely with the Regulatory Affairs Team, Regional Regulatory Project Managers, and external service providers (artwork, publishing) to ensure timely completion of various regulatory activities
Duties
- Tracking and management of various project components to ensure project milestones are met
- Artwork approvals, product information updates
- Dossier preparation and submissions – Cat 3 applications
- Maintenance of product registrations
- 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
How to Apply
Click apply or contact Davina Ocansey, Sourcing Consultant on +61 2 8877 8712 for a confidential discussion.