Regulatory Affairs Officer

Summary about this job

Detail information about job Regulatory Affairs Officer. Terms and conditions vacancy

Evolve Scientific Recruitment are proud to be partnering with QIMR Berghofer to recruit a Regulatory Compliance Officer for the Q-Gen Cell Therapeutics facility.


About Q-Gen

Q-Gen Cell Therapeutics is a fully integrated facility for translational research within QIMR Berghofer providing GMP manufacturing facilities for translating QIMR Berghofer's clinical research to the bedside. Capitalising on the expertise of QIMR Berghofer investigators, Q-Gen Cell Therapeutics has a solid track record in adoptive T cell therapies for Phase I and Phase II clinical trials.

Based in Herston, Brisbane and working in close collaboration with clinicians and other research institutes, QIMR Berghofer is the home to more than 600 scientists, students and support staff.


About the Role

The Regulatory Compliance Officer position is a full time, fixed-term contract role based in Herston, Brisbane. The core responsibility of this role is to provide expert advice on regulatory compliance matters to ensure the effective, efficient and safe manufacture of GMP grade cell therapy products at Q-Gen Cell Therapeutics.


Responsibilities include:

• Provide expert advice on the regulatory requirements for cell therapy manufacture, dispositions and clinical trials in all relevant jurisdictions;
• Maintain detailed knowledge of existing and emerging regulations regards cell therapy manufacture;
• Assist in ensuring the quality and production system and processes comply with all relevant legislation and codes for GMP, including the maintenance of TGA licensing for GMP manufacture;
• Assist in responding to regulators;
• Deputise for the Quality Assurance Manager, as required.

Salary commensurate with experience please see below for benefits offered.


Selection Criteria:

To be considered for this position please submit an application addressing the following selection criteria:

• A Tertiary qualification in Science;
• Solid knowledge and expertise in GMP regulations for cell therapy manufacture and clinical trials in Australia, USA and Europe;
• Knowledge of TGA requirements is an advantage;
• Exceptional attention to detail and the ability to interpret and translate complex codes into Standard Operating Procedures;
• Excellent verbal and written communication skills with the ability to provide advice and ongoing education to senior management, scientists, clinical staff and regulators on all regulatory aspects of GMP for cell therapy manufacture;
• High level organisational skills with the ability to manage conflicting priorities;
• Additional qualifications in Internal Auditing and/or Business Management would be highly regarded;
• A high level of competency with Microsoft Office.

NOTE: Shortlisting for this role will commence immediately, so we encourage you to apply now.


Benefits & Culture:

There are fantastic benefits included in this position as follows:

• Salary Packaging
• Bonus Superannuation
• State of the art facilities
• Stimulating work setting focussed on cutting edge medical research
• Supportive/collaborative team environment

How to apply:

Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume.
Where possible we would prefer MS Word documents as sometimes PDFs may be corrupted and your application may not be processed. For FREE resume and cover letter templates and other job-seeking resources to strengthen your application, go to www.cteaa.com.au
Please note: we accept applications only from Australian and New Zealand residents with valid Australian work rights; this includes temporary residents on visas such as the Working Holiday Visa.


Need more info:

Contact the Brisbane Office on 07 3175 0680 or at www.evolvescientific.com.au.


How to Register with Evolve:

If this role isn't for you but you want to register with Evolve for upcoming positions please click on the "Apply Now" button and ask to be registered for other roles.


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Why Evolve Scientific Recruitment?

www.evolvescientific.com.au
Evolve (QLD Labour Hire Licence Number: LHL-00906-L1D2V) specialises in scientific/technical recruitment in:
• Pharmaceutical, Food, Biotechnology, Chemical, Petrochemical, Environmental, Health Services, Life Sciences, Mining and more.
• Adelaide Brisbane Melbourne Perth Sydney


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