Regulatory Affairs Manager

Ardern Healthcare Limited is a rapidly-growing global specialty medical and pharmaceutical company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world.  The company consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines.  Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

Ardern Healthcare Limited is a rapidly growing company that has a great future ahead. To sustain our growth we are always on the lookout for highly motivated, ambitious and committed individuals to join our highly successful team.

ROLE

The Key responsibilities for this role are:

Operational

Regulatory responsibility for allocated projects on global licensed products within Ardern Healthcare Limited including applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses to Ardern Healthcare Limited

Provide coaching and mentoring in specific areas of expertise to junior members of the department

Ensure that all regulatory activities comply with current Regulatory Agencies requirements and guidelines

Develop and maintain effective external business relationships

REQUIREMENTS

Bachelor's Degree (or preferably higher degree) in Life Sciences or scientific discipline