NPI Regulatory Affairs Officer

NPI Regulatory Affairs Officer

Role: New Product Introduction - Regulatory Affairs Officer

Location: Mulgrave

Industry: Pharmaceutical

Salary: Negotiable on experience

Responsibilities:

To provide regulatory support to internal and external stakeholders, manage ARTG entries, and provide regulatory advice for product artwork review. Ensure local and relevant international regulatory and safety requirements are addressed for all formulations developed by the R&D group.

Day to day:

1. Ensure that the required technical, safety and regulatory detail is sourced for all new RMs to be used in the development or operational environments and that these are correctly entered in the appropriate systems.

2. Respond to internal and external queries regarding RMs used by contacting the relevant supplier or regulatory body.

3. Ensure that the regulatory s...