Senior Regulatory & Quality Expert

EMD Group · Shanghai, CN

Posted Jul 22, 2026

The candidate will be a key regulatory & Quality expert for the portfolio of Life Science, Pharma & Biotech industry. The candidate should have an understanding of regulatory & quality for sterile drugs/biopharmaceuticals, including<s> </s>IND/NDA process, GMP and relevant regulations.

In addition, the candidate must be well-versed in regulatory trends relevant to Life Science products. Your Role:<ul style="margin-bottom: 0.0cm; margin-top: 0.0px;" type="disc"><li>Take active role to build regulatory intelligence for Life Science. Focused area includes upstream, downstream process, raw materials management and new technologies. </li><li>Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of business interests. </li><li>Safeguard LS strategic interests and objectives in arising guidance, standards and regulation. </li><li>Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business.

Analyze available regulatory and compliance information.</li><li>Increases the influence of important regulatory bodies and industry associations. </li><li>Secure flow of information from/to authorities, industry associations.</li><li>Builds and keeps personal relationships to local and national authorities. </li><li>Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards. </li><li>Training for and support of internal stakeholders, external customers and relevant regulatory bodies.</li><li>Builds processes for the flow of information and regulatory intelligence within China. </li><li>Definition of processes to implement upcoming regulatory needs and requirements.</li><li>Provide regulatory & quality expertise and consultation for customer regulatory & quality inquiries, support complaints investigations. Develop the strategy and provide guidance to customers on inspection/audit readiness and drug registration, include process validation, change control, etc. </li><li>Closely work with global regulatory surveillance & advocacy team and Life Science regulatory subject matter experts to link the local advocacy activities with global advocacy activities. </li><li>Monitor competitor approach regarding regulatory requirements. </li></ul> Who you are:Education and Languages:<ul style="margin-bottom: 0.0cm; margin-top: 0.0px;" type="disc"><li>Master/Ph.D.

Life sciences or related science/engineering background with a strong emphasis in biologics/biopharmaceuticals. </li><li>Fluent in Chinese & English (verbal and written) is required.</li></ul> Professional Skills and Experiences:<ul style="margin-bottom: 0.0cm; margin-top: 0.0px;" type="disc"><li>Minimum of 10 years of relevant industry experience in quality & regulatory, CMC, process development and process validation related to biopharmaceutical products. </li><li>Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, Upstream and downstream process. </li><li>Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.</li><li>Experience working in a global, matrix environment. </li></ul> Personal Skills and Competencies:<ul style="margin-bottom: 0.0cm; margin-top: 0.0px;" type="disc"><li>Strong organizational and time management skills.</li><li>Good project management skills. </li><li>Ability to train and educate others.</li><li>Effective management by influence.</li><li>Ability to work in multi-cultural teams.</li><li>Good listening skills with the ability to analyze and respond to given situations quickly and effectively.</li><li>Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.</li><li>Ability to indirectly influence other organizations and cultures.</li><li>Proficient in MS Office Software (Word, Excel, PowerPoint, Project).</li><li>Able and willing to travel. </li></ul>

Originally posted by EMD Group. View original posting

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