Regulatory Affair Associate

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.

**Key Responsibilities**

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

- Analyse and/or assist in the analysis of scientific content of registration packages
- Prepare and submit regulatory submissions to the TG or other associated regulatory bodies and co-ordinate company response during the review process.
- Analyse and/or assist to complete gap analysis on registration dossiers to ensure they comply with government regulations prior to submission.
- Prepare submissions and product information changes to align with government legislation/corporate requirements and/or brand strategy, with cost-efficiency and according to budgetary requirements.
- Review and approve artwork and packaging changes and recommend action.
- Provision of regulatory input/contribution in selection and supply related matters.
- Provide regulatory affairs support for clinical research activities, as required.
- Enhance/create regulatory systems and records in accordance with guidelines (SOP,WI, tracking and compliance)

**Requirements**:

- Bachelor’s Degree in Pharmacology/Pharmacy, Biomedical or related field.
- Minimum 3 years’ experience in regulatory affairs.
- Experience in the preparation and submission of dossiers for prescription pharmaceutical products.
- Demonstrated knowledge of GMP requirements, regulatory requirements, quality systems and technical requirements.
- Experience liaising with regulatory authorities (TGA and Medsafe) and internal and external regulatory personnel.
- Ability to develop and maintain effective working cross-functional relationships.

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

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