Regulatory Affairs Associate

Summary about this job

Detail information about job Regulatory Affairs Associate. Terms and conditions vacancy

Max Biocare is an Australian owned company that develops quality healthcare products for local and international markets. We are an established and trusted brand, with natural formulations based on scientific evidence. Our entire range of therapeutic formulas and non-medicated products are manufactured in Australia in compliance with the Good Manufacturing Practice (GMP) to ensure quality, safety and efficacy. Max Biocare is committed and passionate about helping people live happier and healthier lives.

To support our continued expansion into Asian markets, our head office in Melbourne is looking for a qualified candidate to join our Regulatory Affairs team to assist with the registration of our products into a number of markets including Myanmar, Thailand, Indonesia, and the Philippines.

Reporting to the Head of Regulatory Affairs, you will work within both the Australian and overseas regulatory requirements and have gained relevant experience from similar positions.

Responsibilities include:

·         Liaising with the Australian manufacturers and relevant authorities in Australia to obtain regulatory and technical documentation required by overseas authority or distributors for registration of new therapeutic/health products into the markets that you will be designated to;

·         Preparation of registration dossiers for new or renewal of the company’s products into your designated overseas markets;

·         Communicating with overseas distributors and authorities as required for on-going registration projects;

·         On-going regulatory support to products in the market including but not restricted to keeping updated of changes to the regulations in Australia and in the designated overseas markets and advice the team of these changes, and communicate relevant follow up actions to the overseas distributions to keep the products in compliance with these changes.

·         Facilitating and coordinating communications of all discussions related to regulatory issues between Max Biocare’s regulatory team and the distributors in your designed overseas market.

Qualifications and Experience:

·         Bachelor of Pharmaceutical or Health Science (essential);

·         Minimum 2 years local experience in regulatory affairs within health and pharmaceutical industry (essential);

·         Ability to speak and write one of the following languages: Burmese, Thai, Indonesian, Philippines (preferable);

·         Experience in working in one of the Asian countries in the pharmaceutical or medical industry (preferable).

The ideal candidate should also possess:

·         Excellent attention to details. Excellent communication skills in English and another Asian language;

·         Excellent time management and independence;

·         Well organized and systematic thinking ability;

·         Ability to work in a multi-cultural environment where colleagues speak different languages; and

·           A high level of personal integrity, passion about health and nutrition and well-being as well as the organization’s growth.

Remuneration is negotiable, based on current level of qualifications, professional experience and capability and is between $55,000- $65,000 exclusive of superannuation.

To apply, please attach:

• Your CV, including contact details of 3 referees;
• Cover letter addressing the criteria above; and
• Three writing samples of any writing style and length to showcase the applicant’s English written skills.

Applications close 26th July, 2018