Specific activities and responsibilities:

Provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia and New Zealand and (JAPAC) region.
Provide support to clients with the maintenance of current registrations and listings.
Review, critically evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe.
Act as Project Lead/Manager, participate in assigned projects and support project teams as requested.
Assist clients in responding to TGA and Medsafe questions.
Develop a subject matter expert area(s).
Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
Provide strategic advice to clients regarding the JAPAC regulatory environment.
Preparation, review and update of quality documentation.
Assist with development of proposals.
Build strong interpersonal networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities for Commercial Eyes.
Lead contributor to client retention. Developing strong relationships with existing clients and providing high quality consulting services to build client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the BU’s service offering.

Required education:

Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline.

A minimum of 5 years’ experience in regulatory affairs, preferably in a commercial environment.

English

Experience in the review, critical evaluation and presentation of data for medicine dossiers.
Good knowledge of legislation, regulations, guidelines and working procedures within Australia, New Zealand and the JAPAC region.
High level written and oral communication skills.
Proven problem solving and project management skills.
Reasonable computer literacy.
Ability to deal with high level of confidentiality.
Post-graduate qualifications in a relevant discipline, desirable.
Previous experience in project management and/or consulting.
Willingness to travel as required.