Regulatory Affairs Associate

2 weeks ago

South Yarra, Australia Max Biocare Full time

**29 March 2024**

**Regulatory Affairs Associate**
- **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.**_

This is a long-term, permanent position, suitable for quality-focused individual with excellent attention to detail, have good communication skills in English, Thai and Lao language and have the ability to work in a fast-paced team. Reporting to the Head of Regulatory Affairs, your responsibilities include but are not limited to;
- Liaising with Australian manufacturers and relevant authorities to obtain regulatory and technical documentation required by overseas authority for registration of new therapeutic/health, cosmetic and pet care products into Thailand and Laos market.
- Preparing product registration dossiers to ensure compliance with Thailand and Laos regulations.
- Liaising with overseas distributors in Thailand and Laos and authorities as required for on-going registration projects.
- Providing ongoing regulatory and technical support for products in Thailand and Laos to ensure compliance with any changes or amendments in regulations from both Australia and overseas authorities and advising the team on these changes while communicating relevant follow-up actions.
- Reviewing and approving product specifications to ensure compliance with regulatory standards in Thailand and Laos market.
- Assisting in artwork and labelling lifecycle coordination to ensure compliance with current regulatory requirements in Australia, Thailand, and Laos.
- Facilitating and coordinating communications between Max Biocare’s regulatory team, Thailand and Laos distributors, and providing regulatory support for new product development.
- Reviewing quality documentation to ensure product compliance with its marketing authorisation.
- Being responsible for the quality assessment of finished products to ensure they adhere to product specifications.
- Assisting and maintaining Quality Assurance systems.
- Appropriately conveying to distributors/consumers in Thailand and Laos any investigations regarding product complaint.
- Conducting market research to assist in new product development suitable for Thailand and Laos market.

**Qualifications and Experience**:

- Bachelor of Pharmaceutical or Health Science is essential.
- Minimum 4 years’ experience in regulatory affairs within healthcare, pharmaceutical, cosmetic and pet care industries.
- Strong understanding of GMP and regulatory requirements related to pharmaceuticals, food, cosmetics, and pet care products in Australia, Thailand, and Laos.
- Has experience in working in Thailand and Laos pharmaceuticals, healthcare or cosmetics
- Good verbal and communication skills in English, Thai and Lao languages.
- Excellent attention to detail.
- Excellent organizational and time management abilities.
- Ability to work autonomously and in a multi-cultural environment where colleagues speak different languages.
- Adaptable and flexible in response to shifting priorities.
- Proactive, committed to achieving challenging objectives, forward thinking and success driven.

Remuneration is negotiable, based on current level of qualifications, professional experience and capability and is between $90,000- $95,000 exclusive of superannuation.

**Benefits**
- Supportive workplace culture including flexibility of remote.
- Opportunities to diversify into other areas of the business.
- Annual product allowance and generous staff discounts on products.
- 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 29th April, 2024

**Salary**: $90,000.00 - $95,000.00 per year

**Benefits**:

- Employee discount

Schedule:

- 8 hour shift

**Education**:

- Bachelor Degree (preferred)

**Experience**:

- regulatory affairs: 4 years (preferred)

Work Authorisation:

- Australia (required)

Work Location: In person

Application Deadline: 29/04/2024

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