Regulatory Officer

Văn Phòng Đại Diện Max Biocare Tại Hà Nội

Địa điểm làm việc: Hà Nội

Hết hạn: 23/01/2025

Chi tiết công việc
Giới thiệu công ty

Thu nhập: $ 600-800 /tháng

Loại hình: Toàn thời gian

Chức vụ: Quản lý

Kinh nghiệm: 2 năm

sản xuất communication tiếng anh

Mô tả công việc

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.

Yêu cầu

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:
- $600 - $800
What we offer for this position:
- Competitive salary and allowance package
- Full salary during probation
- 12 days' work from home and 12 days paid annual leave.
- All employee benefits as per Vietnam's labour laws.
- New year bonus
- Flexible work schedule when needed to support personal needs.
- Annual salary review.
- Opportunities for career advancement and personal development.
- Regular training opportunities
Work location:
Hà Nội

Quyền lợi

Chăm sóc sức khoẻ
• Chế độ phúc lợi (BHXH, nghỉ lễ, tết, du lịch...) đúng theo quy định của Luật Lao động và nhiều chế đ
Nghỉ phép có lương
12 ngày
Đào tạo
• Môi trường làm việc hiện đại, làm việc trực tiếp với trụ sở Úc. Cơ hội thăng tiến nghề nghiệp ca

Thông tin khác

NGÀY ĐĂNG
24/12/2024
CẤP BẬC
Nhân viên
NGÀNH NGHỀ
Sản Xuất > Đảm Bảo Chất Lượng/Kiểm Soát Chất Lượng/Quản Lý Chất Lượng
KỸ NĂNG
Quality Assurance, Regulatory Affair, Đảm Bảo Chất Lượng, Dược Phẩm, Pharmacy
LĨNH VỰC
Dược phẩm
NGÔN NGỮ TRÌNH BÀY HỒ SƠ
Tiếng Anh
SỐ NĂM KINH NGHIỆM TỐI THIỂU
1
QUỐC TỊCH
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