Regulatory Affairs Manager (SEA and India)

#21147

Company Info


Hr2b's client

HR2B's Client is global beverage company

Job Information


Work At
Ho Chi Minh
Level
Manager
Function
Quality Control/ Quality Assurance
Industry
Food and Beverage
Consultant
Bui Thi My Tam
Bui Thi My Tam
Tel: +84 028 6288 3888 Ext: 853
- Works with Corporate Regulatory and legal to manage all interaction with the FDA or local Health Bureaus.
- Assist corporate Regulatory during the product registration processes and labeling development.
- Assist bottler QA manager during FDA audits at bottler plants during the registration of new products and plants.
- Manage consumer relations with the trade, local and federal government and the product bottler in coordination with corporate legal and regulatory functions thru the company Consumer Relations program.
- Participates and assist in the remediation of all deviations, nonconforming material and complaints. Develops qualification/validation protocols as necessary.
- Educate company staff and the Coca-Cola bottling groups about to our products.
- Participate in the company Stability and Compliance Program by assisting Product Development and Quality Assurance by writing stability protocols and coordinating testing at the approved intervals to ensure that product and raw materials comply with corporate and regulatory specifications for our food category.
- Develops performance reporting tools to assist management in assessing overall compliance and opportunities for improvement.
- Participates in technical reviews necessary to ensure GMP/Regulatory compliance, including; raw material and finished good specifications, label approval, master manufacturing records, etc.
- Complies with company policies and procedures and maintains regular work attendance.
- Performs other duties as assigned.

Requirements


- Bachelor of Science in Engineering, Life Sciences or other related technical degree is preferred. Related training and experience can be substituted for education.
- Auditing Experience: GMP, HACCP or other regulated industries
- Knowledge and proven experience with local regulatory requirements for beverage, food or health products.
- Minimum 10 years’ experience in a leadership role in Regulatory and/ or Quality Assurance for a food
or health food manufacturer.
- Auditing experience of contract manufacturers and raw materials.
- Working knowledge of Food safety standards and general GB standards
- HACCP trained, certified is preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Experience writing procedures for a regulated industry.
- Other FDA regulated industry experience in a quality or regulatory department.
- Must be able to perform with minimal direction at a high level, must be team-oriented and willing to work collaboratively. Must have demonstrated initiative and desire to work in a dynamic work environment with multiple demands. Must be detailed oriented, analytical and be able to follow written and oral instructions. Must be able to multi-task and follow-up when responses are needed.

Benefits



Contact Information


You can apply online, send your CV or call Bui Thi My Tam at this number
+84 028 6288 3888 - Ext 853



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