Regulatory Affairs Manager

Benefits

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Work with a global company

A seat on the leadership team

Work across a variety of products across Over The Counter, devices and pharmaceuticals

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About the company

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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.

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About the opportunity

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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.

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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

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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

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Culture

Collaborative, supportive and progressive environment.

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How to Apply

Click apply or contact Davina Ocansey, Recruitment Consultant on +61 2 8877 8712 for a confidential discussion.

( SK915184A )

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