Work across a variety of products across Over The Counter, devices and pharmaceuticals
About the company
A long standing family owned pharmaceutical company with a global reach. They always striving to take on new products and therapies through their active partnership programme resulting in a healthy pipeline to invest in.
About the opportunity
Lead the Regulatory and Quality functions in this hands on role to ensure that product registrations and submissions comply with current best practice standards. As a member of the leadership team you will be instrumental in setting up strategic plans and providing oversight for established and new products.
Duties
Develop and manage regulatory strategies for company products
Direct and manage product registrations and submissions
Liaise with regulatory bodies
Performing the tasks of the QMR (Quality Management Representative)
Liaising with ANZ regulators as required in regards to Quality
Supporting regular internal and external quality audits
Supervise and manage the activities of personnel that report to position
Responsible for the professional development for direct reports
Skills and Experience
Tertiary qualification in a relevant scientific discipline or equivalent
Proven regulatory experience across pharmaceutical OTC and devices
A full strategic understanding of the drug development principles and processes
Experience of working on major regulatory applications in ANZ
Experience in regulatory management systems where Veeva RIMS or TrackWise would be advantageous
Line management experience or ability to demonstrate leadership qualities
Culture
Collaborative, supportive and progressive environment.
How to Apply
Click apply or contact Davina Ocansey, Recruitment Consultant on +61 2 8877 8712 for a confidential discussion.
