NPI Regulatory Affairs Officer

3 weeks 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.

Apply Now

  • Procurement Officer

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location ACT   Employment Type Ongoing (Permanent), Full-time  Classification APS Level 6 - $94,563.00 and $107,713.00 plus 15.4% super (part time pro-rata) Contact Officer Kylie Mundy on or    Office Arrangements Hybrid  - Flexible working arrangements can be negotiated in accordance with...

  • Senior Communications Officer

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location VIC; ACT; QLD   Employment Type Ongoing (Permanent), Full-time  Classification APS Level 6 - $94,563.00 and $107,713.00 plus 15.4% super (part time pro-rata) Contact Officer Renee Roszbach at    Office Arrangements Flexible  - Flexible working arrangements can be negotiated in...

  • Senior Communications Officer

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location VIC; ACT; QLD   Employment Type Ongoing (Permanent), Full-time  Classification APS Level 6 - $94,563.00 and $107,713.00 plus 15.4% super (part time pro-rata) Contact Officer Renee Roszbach at    Office Arrangements Flexible  - Flexible working arrangements can be...

  • Temporary Employment Register

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location ACT; NSW; NT; QLD; SA; TAS; VIC; WA   Employment Type Ongoing/Non Ongoing (Permanent/Temporary), Full-time / Part-time  Classification APS4, APS5, APS6, EL1 $76,863.00 and $134,865.00 plus 15.4% super (part time pro-rata) Contact Officer Cameron Milliken on or    Office Arrangements ...

  • REGISTER - APS2 - WA - Casual and Non-Ongoing Assistant Border Force Officer 2025/2026

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID ABF -  Location WA  Employment Type Non Ongoing (Temporary) - Full-time/Part-time, Casual/Intermittent - Non-ongoing employment for a specified term may be offered for an initial period of up to 12 months, with the possibility to extend. Classification APS Level 2 - $59,520.00 and $66,115.00 plus 15.4% super (part time...

  • Policy and Program Officer/s

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location ACT; NSW; NT; QLD; SA; TAS; VIC; WA   Employment Type Ongoing (Permanent), Full-time / Part-time  Classification APS Level 6 - $94,563.00 and $107,713.00 plus 15.4% super (part time pro-rata) Contact Officer Luke Davoren -    Office Arrangements Flexible; Hybrid; Onsite  - Flexible...

  • REGISTER - Casual and Non-Ongoing Assistant Border Force Officer 2025/2026

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID ABF -  Location NT   Employment Type Non Ongoing (Temporary), Casual/Intermittent  Classification APS Level 2 - $59,520.00 and $66,115.00 plus 15.4% super (part time pro-rata) Contact Officer Sam Kansal on    Office Arrangements Onsite; Flexible  - Flexible working arrangements can be negotiated in accordance...

  • Senior Border Force Officer

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID ABF -  Location ACT; NSW; NT; QLD; SA; TAS; VIC; WA   Employment Type Ongoing (Permanent), Full-time  Classification APS Level 5 - $84,228.00 and $91,809.00 plus 15.4% super (part time pro-rata) Contact Officer Calynda Jensen on or    Office Arrangements Hybrid; Flexible; Onsite  - Flexible working...

  • Permanent Transfer EL1 Section 26 Register

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location ACT; NSW; NT; QLD; SA; TAS; VIC; WA   Employment Type Ongoing (Permanent), Full-time / Part-time  Classification Executive Level 1 - $115,443.00 and $134,865.00 plus 15.4% super (part time pro-rata) Contact Officer Immigration Workforce Coordination at    Office Arrangements Flexible;...

  • Permanent Transfer APS4 Section 26 Register

    3 weeks ago

    Prayagraj, India Department of Home Affairs Full time

    Job Req ID Home Affairs -  Location ACT; NSW; NT; QLD; SA; TAS; VIC; WA   Employment Type Ongoing (Permanent), Full-time / Part-time  Classification APS Level 4 - $76,863.00 and $82,906.00 plus 15.4% super (part time pro-rata) Contact Officer Immigration Workforce Coordination at    Office Arrangements Flexible; Hybrid ...