NPI Regulatory Affairs Officer

10 hours ago

Prayagraj, India Good People HR Pty Ltd Full time

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 status of RMs used are reviewed and updated based onTGA or other regulatory body notifications

4. Provide product regulatory guidance for both local and international markets to internal and external stakeholders.

5. Manage the listing of developed products and proprietary blends on theARTG and ensure listings are maintained

6. Manage ACE (Annual Charge Exemption) application to optimize the annualARTG listing renewal fees

7.Coordinate the registration of products on the ARTG or APVMA

8. Interface with approved regulatory consultants where external expertise is required

9. Coordinate the generation of SDS for developed products

10. Develop an understanding of the Dangerous Goods Code (ADG.) and assist with queries relating to the labelling, storage, handling and transport of Dangerous Goods

11. Review artwork for therapeutic products and for Dangerous Goods to ensure that artwork complies with the relevant regulations as published by TGA, ACCC, NTA and APVMA.

This role is reporting to the Head of Technical Services and experience of more than 3 years in a similar role is a must.

Only shortlisted candidates will be contacted and PR or Australian Citizenship for this role is mandatory.

IMPORTANT: It is a requirement of all our jobs that you have a PR or AU/NZ Citizenship. A work visa is not sufficient as all our jobs are permanent. Please do not apply if you do not meet these requirements.

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