Regulatory Affair (RA) Officer
Văn Phòng Đại Diện Max Biocare Tại Hà Nội
Job Description
What do we expect from you
• Holding a Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or a related field.
• At least 2 years of relevant post‑graduate experience in a similar role.
• English proficiency is essential, with reading and writing skills equivalent to IELTS 7.0 or above.
• 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 manage multiple projects and tight deadlines.
• Team‑focused mindset, with the ability to communicate effectively across Max Biocare Group’s internal departments and offices.
• Open to learning, continuous improvement, and adapting to change.
• Ability to work independently, responsible and reliable with minimal supervision.
Report to
• QA and Regulatory Affairs Managers
Means of communication
• Microsoft Teams
• Telephone
Communication
• Sales staff members in Vietnam and overseas.
• Quality and Regulatory Affairs staff overseas.
• Distributors, business partners in Vietnam and overseas.
Workday
• Full-time, Monday to Friday.
• Plus 2 Saturday mornings per month.
Salary
Negotiable - depending on skills and experience.
What we offer for this position
• Full salary during probation.
• 12 days work from home and 12 days paid annual leave.
• All employee benefits as per Vietnam Labour Law.
• New year bonus.
• Annual salary review.
• Opportunities for career advancement and personal development.
• Regular training opportunities.
Number of vacancies: 02
• 01 RA Officer – Cosmetics (Chemistry background)
• 01 RA Officer – Pharmaceuticals (Pharmacy background)
Work location
13th Floor, ICON4 Building, 243A De La Thanh street, Lang ward, Hanoi.
Who we are
Max Biocare is a leading Australian company with 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.
Responsibilities
• Prepare quality and regulatory documentation for timely submission to regulatory authorities in countries including, but not limited to, Australia, Vietnam, Singapore, Malaysia, Indonesia, and Thailand for products such as cosmetics, skincare, personal care, nutrition and food, supplements, and pharmaceuticals. Monitor progress and follow up to ensure registrations are granted in time for product launches.
• Prepare and maintain Cosmetic Product Information Files (PIFs) and manage product data in Cosmetri, including creating and updating product formulations, adding new raw materials, uploading and maintaining raw material documents (e.g. specifications, COAs, SDS, allergen documents), and exporting formulation data to support internal teams.
• Participate in artwork and labelling lifecycle coordination to ensure compliance with current Australian and export market regulatory requirements, including checking artworks for accuracy and compliance before printing.
• Prepare and/or review QMS documentation, including SOPs, specifications, and batch manufacturing and packaging records.
• Collate quality system information and data for trend analysis.
• Provide QA and regulatory support for new product development.
• Participate in the investigation of customer complaints.
• Assist with the coordination of Regulatory Affairs and Quality Assurance projects, as assigned.
• Train and supervise junior Regulatory team members (for suitable candidates).
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