Regulatory Affairs Manager
Hết hạn nộp đơn
Mô tả công việc
- 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 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 the company's staff and the 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.
Yêu cầu ứng viên
- 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 Chinese 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.
2. Education, Certification, Licenses & Registrations:
- 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
- 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.
- Travel: Up to 50% traveling
- Computer skills including Microsoft Office
- Knowledge of general statistics for manufacturing operations
4. Physical Demands:
- Light level of physical effort required for a variety of physical activities to include walking, climbing stairs, and standing at a workstation. Ability to talk and hear persons contacted on the job, able to lift and carry up 25 lbs. objects occasionally, able to bend occasionally, able to twist body occasionally, able to ascend and descend ladders.
Quyền lợi được hưởng
- Good benefits
- Theo chính sách của công ty
Cách thức ứng tuyển
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