Regulatory Affairs Lead
Mô tả công việc
1/ Ensure products registration and compliance meet launch schedule for Nutrition category.
- Maintains a working knowledge of all current, product related, laws as well as proposed changes; also, regulations concerning product registration, ingredients, claims, product classification, packaging and product labeling.
- Keeps current with legislation up-dates and the communication of those to US headquarters.
- Contribute to validate product composition & specifications, create and /or validate labeling and packaging design/layout of
- Amway products by formulating recommendations based on regulatory framework, self-regulation, Amway’s guidelines and policies.
- Ensure registration process is on time and meet launch schedule.
- Ensure that the product has been registered and is being sold in a way that is always legitimate, when the product qualification has been changed or with the changing of the rules by the government.
- Ensure the alignment of project deliverable within stakeholders throughout the project cycle.
- Provide technical substantiation and ensure all company advertising materials to comply with all relevant internal policies and Vietnam regulations.
2/ Enabling favorable business environment with target scientific community/ Association and MoH to protect existing businesses and enable new market access for Nutrition category.
- Contributes effectively to influence the direction of change or development of local legislation/ regulatory towards the benefit of the Corporation in accordance with the pertinent local legal procedures and industry standards.
- Build strong relationship with the different registration authorities and academics.
- Provide technical resources to support for post-market government inspection.
3/ Provide Technical Services for Nutrition category.
- Serves the affiliate in all technical matters relating, but not limited to, environment, Good Manufacturing Practices, Good Distribution Practices, environment and Product Developments.
- Must be prepared to respond to Government inquiries diligently based on accurate technical information.
- Functions as technical liaison both within the area of responsibility and with headquarters in the US.
- Represents the Affiliate and the Corporation in Technical and Regulatory matters arise from Government Agencies, Trade Associations and Professional Organizations.
- Works in a consultative role with affiliate management to assist in the development and attainment of Affiliate goals.
- Validate communication to public:
- Provide regulatory risk assessment on all communication materials.
- Contribute to competitive intelligence by analyzing what exists on the markets.
- Provide scientific information for customer's queries for easing their business
4/ Build trust and credibility to maintain good relationships with related entities - academic, government and private sectors.
- Establishes sound communication and working relationships with US headquarters as well as with all other company Affiliate personnel, Affiliate peers, suppliers, consultants, legal counsel, public academic and government agencies, professional and trade associations.
5/ Team Management
- Reponsible for leading & coaching down-lines about knowledge, process… related to assigned categories.
- Coach and develop their expertise and work competencies
- Regularly conduct performance feedback conversation
Yêu cầu công việc
- At least 5-7 years of experience in Regulatory Affairs for consumer products, healthcare products.
- Bachelor's Degree or above in Food Science or Health and Nutrition, with studies in Chemistry, Biology, Bio-Chemistry, Chemical Engineering, Pharmacy/ Industrial pharmacy or related field.
- Experience working for multinational corporations is preferred.
- Must have knowledge of consumer product regulations and standards
- Must be proficient working with business software.
- Excellent in communication & presentation skills (both verbally and written) in technical data to influence others
- Strong verbal and written communication skills in English
- Business acumen with decisive decision making
- Strong people management skills, ability to influence & motivate team member
- Good analytical & logical thinking & planning ability
- Has positive attitude & high level of maturity, strong sense of responsibility
Các phúc lợi dành cho bạn
Thưởng
Chăm sóc sức khoẻ
Đào tạo
Thông tin việc làm
22/11/2024
Trưởng phòng
Sản Xuất > Đảm Bảo Chất Lượng/Kiểm Soát Chất Lượng/Quản Lý Chất Lượng
Regulatory Affair, Đăng ký sản phẩm, Product Registration, Pháp Chế Dược, Health Supplement
Dược phẩm
Bất kỳ
5
Không hiển thị
Địa điểm làm việc
410B,C,D Nguyễn Thị Minh Khai, Phường 5, Quận 3, Thành phố Hồ Chí Minh, Việt Nam
HCMC AMWAY CENTER - 410B,C,D Nguyễn Thị Minh Khai, Phường 5, Quận 3, HCMC
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