Xsite Regulatory Compliance Specialist

Posted 19 Nov 2021

Nantong, Jiangsu - China

Req Id 234042

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 352 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Xsite Regulatory Compliance Specialist

(Nantong based)

 

Part of the Global External Supply Quality organization, Xsite Regulatory Compliance is a global function supporting the External Manufacturing of our company medicinal products in compliance to the Product Registration.

The position of Xsite Regulatory Compliance Specialist is at the interface between Global Regulatory Affairs and the External Manufacturers.

 

 

Your Role:

 

In support to the Xsite Regulatory Compliance program, you prepare Products Regulatory Compliance Files (compilation of relevant registered manufacturing processes, analytical methods and specifications) and make them available to External Manufacturers (located in China and other markets).

 

You perform regulatory assessment of change requests submitted by external manufacturers requiring regulatory submission.

 

You determine nature and scope of information necessary for the generation of the variation, obtain and evaluate the technical data from External Manufacturers (Validation protocols and reports, Stability data, …).

 

You monitor the regulatory approvals and coordinate them implementation at the External Manufacturer Sites.

 

You interact with various departments as needed on regulatory compliance strategy. You effectively guide, communicate, and implement determined strategy with the appropriate departments and/or stakeholders.

 

You can be primary contact with regulatory authorities for assigned projects and products externally manufactured in China.

 

You are responsible for liaising with our company Regulatory Intelligence and keeping your stakeholders informed about upcoming regulatory changes and supporting the management of change/risk as appropriate.

 

You develop and maintain product registration dossiers in support of Marketing Authorization applications and License for products externally manufactured in China.

 

 

Who you are:

Requires a degree (e.g., Pharmacist, Chemist, Engineer) that provides knowledge of theories, principles and concept within Pharmaceutical Quality Management System and Manufacturing and Testing of medicinal products.

Requires Regulatory compliance experience in the pharmaceutical/biopharmaceutical industry, medical or life science (about 8 years as a guide). Knowledge of international regulatory affairs and Good Manufacturing Practices is preferred.

Requires extensive knowledge on a broad scope of quality regulation, good understanding of external compliance trends and ability to address needs based on external demand.

Excellent communication skills, ability to influence key stakeholders, strong negotiation skills and ability to develop creative idea for conflict resolution.

Business fluent Mandarin and English.

 

HR: 95777

Functional Area: Quality

 


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