默克投资(中国)有限公司新闻资讯

Your role:

Reporting to QMS Manager, Senior Regulatory Compliance Expert will take responsibilities on CMC dossier lifecycle management, including creation and maintenance, as well as responsible for regulatory assessment, to ensure site all product compliance with all regulations and company requirements.

In this role, you lead optimization current regulatory compliance process based on MAH full responsibility from whole drug product lifecycle. And be responsible for development, organization and execution of the company’s regulation policy, to ensure that product manufacturing and control are compliance with registration dossier and Domestic regulatory.

You review and approval of change controls, under the aspect of regulatory compliance and possible actions, ensure MNT change control management comply with China GMP and related regulation requirements

you lead the interaction with Health Authorities and govern the GMP Site License management. Build and maintain a positive and solid relationship with Health Authorities as well as industry, such as RDPAC membership and local pharmaceutical industry associations etc.

You ensure the effectiveness and compliance of the manufacturing certificate, GMP certificate of site.

You lead the regulatory intelligence, identify the risk & mitigation with coordination from RA and global resources, ensure the product safety and compliance. Keep the monitor of regulatory development trend, to assist the strategy decision making for Site.

You lead and organize the regulatory relevant assessment and strategy decision making, identify the risk and mitigation with coordination from Regulatory Affairs and Global stakeholders to ensure the product quality, safety and compliance.

You support excipient and packaging material bundling review for localized pharma manufacturing in Nantong Site.

You are responsible for approve and release PPIF and corresponding artworks in the Global Artwork Management System.

  Who you are:  

• BS in Natural Science (Pharmacy, Chemistry, Biology, or a related pharmaceutical science).

• Five (5) years of experience within the quality operation of the pharmaceutical/health care industry

• Familiar with China GMP and Chinese regulations and requirements.

• Result orientation, accuracy and reliability as a must

• Business fluent English

• Excellent communication, problem-solving, planning and organization skills

• Experience and knowledge in regulatory affairs

• Project management and Six sigma Belt or Lean expert preferred