Regulatory Affairs Associate Manager

Benefits

• Oncology/Haematology therapy area products with strong pipeline

• Work on novel applications

• Flexible working arrangements

• Partner with larger biopharmaceutical organisations

• Support of a highly experienced manager

About the company

A global, 11-year-old research-based, biotechnology organisation with a focus on innovative oncology products. They have a newly acquired headcount within their regulatory team in Australia reporting directly to the Senior Regulatory Affairs Manager. The company are passionate about their product pipeline and currently have ongoing clinical trials where they have potential products in the double digits. With products already registered in the USA, China and Australia they are currently working on expanding into further countries. They have partnerships with larger biotechnology organisations to allow them to broaden their reach and product pipeline

About the opportunity

Working on novel oncology submissions and reporting to a highly experienced Regulatory Manager your main responsibility will be to ensure regulatory compliance of the prescription product portfolio. As a Senior Regulatory Affairs Associate/Associate Manager you will work autonomously and will come with broad understanding of the regulatory requirements of the pharmaceutical product life cycle.

Duties

• Plan and manage regulatory activities for Australia and New Zealand relating to assigned projects that span technical areas including clinical, non-clinical, and CMC.

• Assist in developing and implementing strategies of regulatory submissions

• Manage the preparation, review, and timely submission of all components of regulatory dossiers as required for investigation and registration of products

• Ensure regulatory submissions are maintained in compliance with ANZ regulatory requirements.

• Provide expertise on regulatory matters.

• Develop and maintain current regulatory knowledge and advise management of significant developments.

• Work with external regulatory consultants/CRO's as required.

Skills and Experience

• Minimum of 3 years regulatory affairs experience working with pharmaceuticals

• Understanding of TGA and Medsafe regulatory requirements

• NCE & Cat 1 experience required

• Clinical Trial Notification (CTN) experience would be advantageous but not essential

• Experience with CTD/eCTD

• Detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

• Effective verbal and written communication skills are a must as well as superior planning skill

Culture

Strong work ethic, determined, dedicated, and driven to achieve targets. Transparent and honest working together to meet common goals. Collaborative and autonomous where the culture is evolving due to the implementation and growth of the business. Be part of growing that culture and shaping the future of this growing organisation

How to Apply

Click apply or contact Angela Barclay, Associate Director on +61 2 8877 8743 for a confidential discussion.

( SK915184A )

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