Regulatory Affairs Associate

Job description

Job Description

To evaluate, submit and maintain registration dossiers for the Australia market and to ensure compliance with all corporate and local requirements.

Key responsibilities include:
- Preparation, submission and maintenance of registration applications to the Therapeutic Goods Administration (TGA) and Medsafe (New Zealand) within the agreed timeframes assigned by the Regulatory Affairs Manager 
- Review of existing registration dossiers to identify administrative and technical deficiencies that may influence the likely success or failure of the application; 
- Development of strategies to overcome deficiencies in the registration dossiers; 
- Liaison with international parent and license companies for the acquisition of documentation, information, product samples and responses to issues raised during re-view/evaluation of registration dossiers; 
- Management of regulatory affairs activities associated with the maintenance of registered product portfolio; 
- Creation and review of Product Information and Consumer Medicine Information documents for registered products; 
- Provide technical and/or strategic regulatory advice to internal cross-functional teams; 
- Preparation of the regulatory data set for applications to the Pharmaceutical Benefits Branch for product reimbursement; 
- Management of regulatory processes to point of market launch; 
- Provide support for the preparation and set-up of bioequivalence studies; 
- Provide regulatory support, technical and/or strategic regulatory advice for product development and pre-submission activities.
- Other responsibilities for the position include participation in departmental meetings, establishment of a good rapport with local TGA regulators and Medsafe regulators.

Desired profile

Minimum requirements

Tertiary education in Pharmacy, Science, Chemistry or related English Minimum of 2 year industry experience required Ethical experience preferred