Senior Regulatory Affairs Specialist

About the Company
A distinguished biopharmaceutical company focused on preventing illness with vaccines and providing ground-breaking treatments to enhance the lives of patients worldwide. The company strives to transform scientific innovation with a patient centric approach to ease the pain of those who suffer from rare and chronic illnesses.

About the Opportunity
You will be utilising your expertise to implement strategies that optimise all stages of the product life cycle and enhance patient access to new products. By driving strategic priorities, you will maximise business opportunities and achieve operational excellence ensuring regulatory compliance.

This role reports to the Head of Regulatory Affairs, and sits within an experienced regulatory affairs team. You will work closely with other Regulatory Project Managers and share information to ensure timely approvals for existing and pipeline innovative pharmaceutical products.


Duties

• Develop regulatory strategies to maximise business opportunities for both new product registration and ongoing life cycle management
• Support activities to influence the regulatory environment through contribution to industry groups and consultations to drive the strategic priorities.
• Support the development of the regulatory team to enhance and maintain performance
• Develop and maintain excellent relationships with health authorities to effectively negotiate timely approvals and optimal product labelling and risk minimisation strategies.
• Keep abreast of regulatory environment as well as industry changes and advise of impact to the company
• Ensure resources and outsource arrangements are managed to enable effective delivery of regulatory strategies across all human health business units and maintenance of compliance.
• Manage the regulatory review of materials as well as the systems utilised to track compliance

Skills and Experience

• Bachelor’s degree in a scientific related discipline
• Minimum of 5+ years experience in regulatory affairs working with innovator pharmaceutical company
• Proven experience securing Cat 1 application approvals and preferably have experience with NCE approvals
• Demonstratable experience of successful engagement with regulatory bodies, TGA and Medsafe
• Excellent verbal and written communication skills
• Team player with ability to mentor junior team members
• Proficiency in Microsoft Office applications

How to Apply
Click apply or contact Joanna Murphy, Specialist Manager on 02 8877 8718 for a confidential discussion.