Sharing Support Officer

 

Description:

Division Responsibilities

The Therapeutic Goods Administration (TGA) is part of Australian Government Department

of Health and Aged Care and is responsible for safeguarding and enhancing the health of the

Australian community through the effective and timely administration of the Therapeutic

Goods Act 1989. The TGA’s overall purpose is to protect public health and safety by

regulating therapeutic goods, such as medicines, medical devices, biologicals, human blood,

blood products and tissues. The Medicines Regulation Division (MRD) is responsible for

undertaking evaluations of applications to approve new medicines and variations to existing

medicines for supply in Australia. The Division also has responsibility for ongoing monitoring

of medicines approved for supply in Australia to ensure they continue to maintain an

appropriate level of quality, safety and efficacy following entry into the Australian

marketplace.

The division includes:

• Prescription Medicines Authorisation Branch (PMAB)

• Scientific Evaluation Branch (SEB)

• Pharmacovigilance Branch (PB)

• Complementary and Over-the-counter Medicines Branch (COMB)

• International Regulatory Branch (IRB)

 

Branch Responsibilities

The Prescription Medicines Authorisation Branch (PMAB) is responsible for evaluating new

chemical entity prescription medicines, leading to an approval or rejection decision.

Through evaluating the clinical aspects of clinical medicines, PMAB ensures medicines

available for supply in Australia are safe, fit for their intended purpose and available in a

timely manner. The branch also approves clinical aspects of variations to registered

medicines and participates in a number of transparency initiatives.

Section Responsibilities

The Application and Advisory Management Section coordinates the registration process for

prescription medicine applications for new medicines, extensions of indication, product

information changes, major variations to register entries and minor variations that involve

the evaluation of non-clinical and/or clinical data. The Section also coordinates pre-

submission meetings with potential sponsors and manages queries from sponsors,

evaluators, decision delegates and administrators. The Section is also integral in

implementing the international work-sharing initiatives and manages the external

evaluation workflow and team.

 

Key Responsibilities

• Analysing information on comparable overseas regulators’ registration pathways and

electronic lodgement of applications associated with the prescription medicines

registration process.

• Developing and managing international collaboration associated with work-sharing

initiatives.

• Assisting in the proactive communication and management of current work-sharing

pilots.

• Administrative processing, tracking and ongoing support for all international work-

sharing initiatives across ACCESS, Project Orbis and COVID-19, and administrative

support throughout the prescription medicines registration process.

• Liaise with internal evaluators concerning their availability to undertake evaluations and

participate in work-sharing initiatives.

• Using technical knowledge of the regulatory framework to explore and apply innovative

solutions to ensure delivery of the work program.

• Ensuring that the relevant evaluation materials are sent to the evaluator and

deliverables are received on time.

• Managing enquiries from internal and external stakeholders regarding international

work-sharing applications and assist with enquiries in the case management streams.

• Drafting relevant Milestone 2/3/5 letters for the AAM section delegates.