Covance

Logistics Regulatory Manager

Job Location(s) CN-Shanghai
Job Number
2021-58534
Job Category
Logistics/Shipping
Position Type
Full-Time
Telecommute
No

Job Overview

The incumbent will be responsible for process development and local management of logistics regulatory activities.
 
The incumbent will be accountable for ensuring day-to-day Logistics operations, would meet regulatory requirements (and other incoming policy changes shared by Regulatory Relationship Manager), with main focus on import/export activities. This role will support all lab-functions within R&D and within Logistics. Discuss with China regulatory for immediate solutions, should a Logistics operational and supply chain challenge been identified. Oversee the process of import/export permit applications covering all Covance labs. Initiate discussions with Regulatory Relationship Manager, on operational challenges that require long term solutions or negotiation with China regulatory. As needed, perform risk assessment together with Regulatory Relationship Manager, and share with Covance internal stakeholders & management.
 
The incumbent must demonstrate proactivity, superior problem solving, communication and presentation skills and ability in communicating clearly/effectively with upper Management
 
The incumbent will be the primary point of contact for Chinese regulatory bodies.
 
The incumbent provides local support to the Logistics team when required.
-Contributes to the development and execution of the Global Logistics Operating Plan in terms of regulatory requirements, and other incoming policy changes shared by Regulatory Relationship Manager.
 
-Research and determine import and export requirements of international and country-specific regulatory bodies (MOH, CIQ, DOH, SFDA etc.) in China and current countries serviced. As needed, work with Regulatory Relationship Manager, to perform deeper dive into the regulations.
 
-Develop and implement appropriate communication channels to support all functions in China across R&D Labs for their specific regulatory requirements.
 
-Develops systems that assure compliance with regulatory requirements across the R&D Labs and Logistics vendors (couriers, customs broker), monitors compliance with procedures and practices.
 
-Work in cooperation with the internal departments, logistics vendors and external regulatory bodies to ensure a seamless flow of supplies movement to meet needs. Initiate discussions with Regulatory Relationship Manager, on operational challenges that require long term solutions or negotiation with China regulatory. As needed, perform risk assessment together with Regulatory Relationship Manager, and share with Covance internal stakeholders & management.
 
-Establish emergency contingency and shipment recovery plans and procedures to compensate for regulatory changes that may disrupt operations, such as customs closings, etc.
 
-Understand documentation requirements for international shipping and country-specific regulatory compliance, including dangerous goods regulations and restrictions, what level of detail is necessary, and what forms are needed and strictly comply with these requirements.
 
-Oversee the process of import/export permit applications covering all Covance labs. As needed for international shipments leaving Covance China labs, understand the importation requirements of destination countries.
 
-Effective and timely adherence to management communications, meetings and procedures.
 
-Strict adherence to company corporate policies
 
-Perform other duties as assigned by the Global Logistics management.

Education/Qualifications

Minimum Required: Bachelor Degree ideally within Economics/Business field, or 5 years experience in clinical trial logistics
 
Nice to Have: Any further Specialization/Certification within the Supply Chain/Logistics field.

Experience

- Minimum of 5 years of proven experience in Logistics and/or Transportation within the CRO industry, or a reputable international transportation company or an international industrial company with track records of managing Logistics team
- Minimun of 5 years of proven experience managing regulatory for an international company managing import/export of regulated materials and requiring regular contacts with government officials.

 

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