Head of Regulatory Affairs

2 days ago

Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

**About Aegros**

Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.

At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.

Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collected into life saving hyperimmune products.

**About the role**

We are seeking an experienced person to join our Regulatory Affairs team to perform a range of tasks including:

- Develop regulatory strategies to maximise business opportunities for both new product registration and ongoing life cycle management
- Ensure Aegros’ products are compliant to regulatory requirements.
- Perform and maintain products registration for Aegros’ products.
- Support activities to influence the regulatory environment through contribution to industry groups and consultations to drive the strategic priorities.
- Support the development of the regulatory team to enhance and maintain performance
- Develop and maintain excellent relationships with health authorities to effectively negotiate timely approvals and optimal product labelling and risk minimisation strategies.
- Keep abreast of regulatory environment as well as industry changes and advise of impact to the company
- Ensure resources and outsource arrangements are managed to enable effective delivery of regulatory strategies across all human health business units and maintenance of compliance.
- Manage the regulatory review of materials as well as the systems utilised to track compliance

**Requirements**:

- Life Sciences (Chemistry, Microbiology, etc.) academic degree with Professional experience (5 to 8 years) in managing and conducting Quality Assurance / Quality Management System functions in Pharmaceutical / Biopharmaceutical industry within Australia and Internationally.
- Professional membership with Regulatory Affairs organization is beneficial (eg. RAPS)
- Experience with regulatory submissions is preferred

**Benefits**
- Supportive and friendly team
- Access to on going training and development opportunity
- Rewarding culture
- Weekly Fruits
- Birthday Celebration

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