Regulatory Director

Job Description

1. Provide the planning and leadership to the Regulatory department by ensuring that appropriate structures, systems, competencies and values are developed.
2. To have overall responsibility for the management of the regulatory department and ensure that new chemical entities, new dosage forms and new indications are registered in a timely fashion.
3. Actively participate on Medicines Australia committees and analyse regular Medicines Australia correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues.
4. Provide regulatory expertise to global product development and regulatory teams.
5. Establish ongoing liaison with key opinion leaders, government officials, and TGA staff and ensure that significant developments in the field are identified and monitored.
6. Represent the company at TGA discussions regarding the registration of new chemical entities.
7. To have overall responsibility for ensuring that all state and federal regulatory requirements are addressed.
8. Ensure that all adverse events are dealt with in accordance with company SOPs and GCP.
9. Form informal networks with company senior management, updating them regularly on regulatory developments.
10. Ensure that the interfaces between Regulatory and other departments are managed optimally.
11. In conjunction with senior management colleagues develop strategic plans whereby both new chemical entities and existing products are considered by Regulatory, Clinical, Marketing and Finance departments through cross-functional teams, to ensure the timely entry of new compounds to the market and the ongoing success of existing products.
12. Ensure effective team communication throughout the Regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.
13. Provide coaching to the Regulatory Associates in various aspects of management (HR issues, budgets, resource allocation).
14. Have responsibility for the financial management of the regulatory budget.
15. Ensure that the Regulatory department provides a value added function to marketing including working collaboratively on product promotional plans and representative training activities.