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Job details

Location
Sydney
Salary
$110000 - $120000 per annum
Job Type
Full Time
Ref
BH-40765
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
21 days ago

Job details

Location
Sydney
Salary
$110000 - $120000 per annum
Job Type
Full Time
Ref
BH-40765
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
21 days ago
Benefits
• A role for an experienced Regulatory Affairs Associate.
• Opportunity for career development and progression within the team.
• Hybrid working & competitive salary package on offer.

About the company
Our client is a leading regulatory consultancy - they are renowned locally and have a strong presence in the national market. Their expertise lies in providing regulatory support to various pharmaceutical Industry leaders.

About the opportunity
This is a great role for someone with a background in the pharmaceutical industry to take on a challenging and rewarding role in a fast-paced environment. As the Regulatory Affairs Associate, you will play a crucial role in maintenance activities of pharmaceutical products ensuring compliance with relevant regulations. In this role you will submit timely applications and respond to regulatory agency requests for information.

To be successful in this role, you will need to be results-oriented, self-motivated, and able to work autonomously. You will also need to have a good understanding of the TGA submission process and be able to provide accurate and timely regulatory advice. This is an exciting opportunity to join a close-knit team of professionals who work together to bring products to the market and manage their lifecycle.
A permanent position with the opportunity to work from home.


Duties
• Ensuring timely submission and responding effectively and efficiently to Agency RFIs to achieve a favourable outcome.
• Provide accurate and timely regulatory advice to the business teams.
• Review and approve advertising materials in compliance with regulations.
• Assess and provide regulatory assessment to Change Control Requests in a timely manner.
• Proactively provide accurate and timely regulatory support and advice to local business teams.

**Please note, the ideal candidate has unrestricted working rights in Australia

Skills and Experience
• Tertiary qualifications in a pharmacy or a life science discipline.
• 3+ years of experience working in the Australian pharmaceutical industry in a regulatory affairs role.
• Knowledge of Australian and New Zealand medicine and medical device regulatory requirements and processes.
• Good understanding of the advertising code of practices and some experiences in reviewing promotional materials.
• Effective written and verbal communications.
• Self-motivated & results orientated.

Culture
An incredibly supportive and harmonious team culture that fosters collaboration.

How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on 02 8877 8776 or Erin Cox, Sourcing Consultant on 02 8877 8734 for a confidential discussion.

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