Regulatory Affairs Specialist

Benefits

Open plan, high energy offices

Collaborative organisation where employee opinions are recognised and actioned

Flexible working arrangements across home and office

Established leadership team with longevity within the organisation

Attractive package including car allowance and other benefits

About the company

An International organisation with around 60 staff in Australia, our client, who is an equal opportunity employer, boasts brands that are some of the best known across the globe. Their reach is further developed through their partnerships with distributors. With a significant household product range that is ever expanding they demonstrate their focus on continuing to bring new and innovative products to consumers through their New Products Innovation Team

About the opportunity

This is an exciting opportunity for a Regulatory Affairs Specialist to be the responsible regulatory person for the organisations many product portfolios. The role will report to the Director of Operations, working alongside a QA/RA colleague, and will hold responsibility for developing and implementing regulatory strategy for assigned portfolio, maintaining and developing products, regulatory planning and preparation for new product applications, liaising with health authorities and agencies, ensure compliance of regulatory requirements throughout the product life cycles and ensure best practice in developing local operating instructions.

Duties

• Complete responsibility will be held for all regulatory affairs activities to provide leadership and successful execution of regulatory strategies and business plans. This will be achieved through cross functional activities to ensure growth and maintenance of valued and respected brands

• Scope all regulatory activities encompassing maintenance and development which will involve liaising with relevant Health Authorities and governing bodies.

• Consider wider business objectives and priorities to ensure common organisational goals

• Ensure that all registration renewals are achieved within timelines to ensure continuity of sales to the wider organisation

• Keep abreast, and up to date, with regards to regulations relevant to the product portfolios

• Continually develop networks to ensure that new products can be delivered to the consumer within the appropriate regulatory frameworw

Skills and Experience

• Minimum 5 years' experience in regulatory affairs with specific focus on consumer and OTC products

• Strong knowledge and demonstrated hands on, up to date experience, of TGA registrations

• Multi tasker, who can work cross functionally across varying projects and tight deadlines

• Ability to work across many product portfolios in an organized and professional manner

• Strong communication and presentation skills

Culture

This organisation boasts a culture of collaboration where they divide and conquer. With high energy and a focus on innovation and achieving results the culture is demonstrative of the tenure of the staff members. Employee opinions are highly regarded where a flexible working approaching boasts a culture of trust a autonomy across the 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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