Head of Regulatory Affairs and Quality

3 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 collect into life saving hyperimmune products.

**About the role**

Reporting to Chief RAQA officer, this position will be responsible to oversee the development, implementation, and maintenance of the company’s Quality System, Regulatory status and filings, and Compliance Strategies to ensure alignment with corporate policies.

**Key Responsibilities**
- Oversee the implementation and maintenance of the quality systems required to support production, laboratory, facilities, quality, production, materials, and packaging / labelling to comply with all regulatory requirements within Aegros
- Ensure compliance of company’s products and processes to regulatory requirements and specifications as stipulated in the product registration, clinical trial registration, and in the various countries regulations where products will be distributed/sold
- Provide strategies and technical advice on:

- product development (including clinical trial design and management),
- product and process technical transfer from Research and Development to an operating facility,
- product registration, and marketing for Singapore, Sydney, and any new project (s) location / region.
- Participate as a key member of the company’s executive leadership team and reporting:

- New regulations,
- Product related issues
- Confirm adequate allocation of resources are available with the appropriate skills for the individual functional groups.
- Oversee post market surveillance and product recall activities. Ensuring there are adequate resources to manage the post market surveillance activities. This will include oversight of the consumer complaints process, review any identified trends, ensure all required complaints are investigated and a root cause is identified and corrective actions implemented, and confirm findings are reported to key managers.
- Develop and communicate established quality control strategies, policies, standards, and procedures to all stakeholders within company and to regulatory authorities, including providing guidance, training, advice, and support to Executive Management of the interpretation and implementation of regulatory requirements.
- Collaborate with the Operations on the design and implementation of an efficient production process and review resources (personnel, material, logistics, schedule, training, calibration, maintenance, etc.), planning, including working with the leadership team to align continuous improvement initiatives with operational, product development, and compliance plans.
- Oversee and approve the compilation of all dossiers (product, clinical trial, and facility) for materials and critical data required for registration of products, including co-ordination of data acquisition by production and R&D team, initiation and management of clinical trials, liaison with regulatory authorities, and handling of all regulatory affairs matters in Sydney, and any new project(s) location / region.
- Oversee the resources that supervise, manage, and motivate the RA/QA/QC and post market surveillance teams.
- Participate as a member of the Company’s senior management team to implement the Company’s policies and goals.
- This position will work independently of operations and finance management when making product quality related decisions.
- Reporting of Compliance issues (which includes QS, Supplier, etc) and contribute positively towards the on-time and within budget delivery of any of the new projects.

**Requirements**:
Preferred is a MS Science (Chemistry, Microbiology, Engineering, Biomedical, etc.) degree
- A minimum of Bachelor of Science (Chemistry, Microbiology, Engineering, Biomedical, etc.) degree or equivalent.
- A minimum of 10 years’ experience in a company that functions within the GMP regulations for pharmaceutical, biopharmaceutical **or equivalent industry (e.g., medical device, baby formula, nutrition manufacture).**:

- A minimum of 5 years in a leadership role

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

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