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Regulatory Manager

3 weeks ago

Melbourne, Victoria, Australia Rainbow Agro Full time

Position:
Regulatory Affairs Manager Australia & New Zealand

Location:
Melbourne or Sydney, Australia

Reports to:
Product Manager Australia

Overview:

Rainbow Agro is a world leading off patent Agrochemical company headquartered in China. It is #1 in China's agrochemical exports. Rainbow's business is backed by a comprehensive list of global registrations allowing Rainbow to conduct and grow the business in more than 80 countries.

The business is supported by 10 manufacturing sites in China, Argentina, Europe, and the USA and the company is actively looking to grow their manufacturing footprint globally. These sites are utilizing Rainbow's unique advanced manufacturing technology which provides Rainbow with a strong competitive advantage. Rainbow is moving to the forefront of the industrial value chain with plans to profitably grow the product portfolio.

Key Responsibilities & Accountabilities :

The Registration Manager is a key member of the Australian team, who will be responsible for the Regulatory aspects of the Australian product portfolio including:


• Developing Rainbow's Australian registration strategy and annual objectives,


• Providing product registration plans for proposed projects which includes data requirements, time frames, and regulatory costs,


• Managing the regulatory aspects of the approved projects to ensure projects are concluded on time and in full,


• Overseeing all registration submissions and applications, which may include

1.Preparation, compilation and submission of dossiers for product registration,

2.Co-ordinating and managing external consultants,


• Maintaining a communication channel with the APVMA and other regulatory bodies to enable monitoring and interpretation of local regulatory requirements,


• Reporting relevant regulatory changes and updates to Rainbow internal teams,


• Defending existing products registrations,


• Providing regulatory expertise, and advice to the business to ensure that portfolio issues, challenges and opportunities are progressed and addressed in a timely manner,


• Establish and optimize Australia registration procedures to enhance the registration efficiency and quality.

This includes but is not limited to:


• Timely Registration of products new to Rainbow,


• Developing and managing relationships with external stakeholders such as the APVMA, 3rd party collaborators, and industry and regulatory experts,


• Suggesting product updates and label extensions to keep existing product relevant and current,


• Preparing annual returns to relevant authorities including the for the APVMA,


• Working closely with the China based regulatory team to ensure a coordinated approach to Australian portfolio.

Experience and Knowledge requirements:


• Hands on knowledge of dealing with the APVMA and their registration submission processes,


• Detailed knowledge of Australian product registration requirements regulatory science issues with multi-year experience in the field,


• Proven ability to deal with complex regulatory issues and to develop effective strategies for managing them,


• High level of attention to detail,


• Demonstrated well-developed communication and presentation skills to facilitate collaboration across functional and geographic boundaries with excellent interpersonal skills


• Ability to work across a broad portfolio,


• Ability to work autonomously,


• Knowledge and experience in working with the New Zealand Ministry of Primary Affairs in dealing with the ACVM Act 1997 and the NZ EPA would be considered highly advantageous.

Please send your CV to below contacts.