Regulatory Affair (RA) Officer

Responsibility:

• Prepare quality/regulatory documentation to ensure timely submission to regulatory authorities in countries including but not restricted to Australia, Vietnam, Singapore, Malaysia, Indonesia, and Thailand for products including cosmetics/skincare/personal care, nutrition and food, supplements and pharmaceuticals; Monitor progress and conduct suitable follow up to ensure registration is granted in time for product launches as per the group’s planning;

• Participate in artwork and labelling lifecycle coordination to ensure compliance with current regulatory Australian and export market requirements, including checking artworks for accuracy and compliance before print;

• Prepare and/or review QMS documentation including SOPs, specifications, and batch manufacturing/packaging records.

• Collate quality system information/data for effective trending purposes.

• Provide QA/regulatory support with new product development.

• Participate in investigation of customer complaints.

• Assist in the coordination of regulatory affairs/quality assurance projects, as assigned.

What do we expect from you:

• Holding a Bachelor of Pharmaceuticals/Chemistry or life science or similar areas.

• At least -2 years of relevant experience after graduation in a similar types of job

• English is a must with Reading and Writing of at least equivalent to IELTS 7.0/

• Excellent Microsoft word and excel skills, good with data presentation and analysis tool

• Excellent attention to details and passionate about being perfect with documentation and details

• Ability to juggle between various tight deadlines and projects

• Team players – ability to communicate with at least within Max Biocare Group’s internal departments and offices

• Open to learning and improvement and constant changes and challenges

• Ability to work independently, responsible and reliable with minimal supervision.

Report to:

- QA Manager and Reg Affair Associate.

Means of communication:

- Email

- Instant messaging: Microsoft Teams

- Telephone

Communication:

- Sales staff members in Vietnam and overseas

- Quality and Reg Affair staff overseas.

- Distributors, business partners in Vietnam and overseas.

Workday:

- Full time Monday – Friday.

- Plus 2 Saturday mornings per month.

Who we are:

Max Biocare is a leading Australian company with nearly 25 years of experience in bioscience and healthcare. We specialise in tailored and effective solutions in phytochemistry, pharmaceutical science, natural product supplements, nutraceuticals, cosmeceuticals, and veterinary health. With a global footprint and a dynamic approach, we're committed to making a positive impact on health and wellness worldwide.

Salary:

- Negotiable - depending on skills and experience.

What we offer for this position:

- Competitive salary and allowance package: $600 - $1000 depending on your qualitfication and experience.

- Full salary during probation

- 12 days’ work from home and 12 days paid annual leave.

- All employee