Senior Regulatory & Quality Expert
On-siteShanghai, Shanghai, China
Job Summary
Build regulatory intelligence for Life Science, focusing on upstream, downstream processes, raw materials, and new technologies. Drive thought leadership by establishing relationships with local authorities and industry associations while safeguarding strategic interests against evolving guidance and standards. Monitor and report on regulatory environment changes, analyze compliance information, and secure information flow from and to authorities. Coordinate internal processes for drafting guidelines and provide expertise on customer inquiries, complaints, and inspection readiness. Support global advocacy teams and define processes to implement upcoming regulatory needs within China.
Required Qualifications
- Master/Ph.D. Life sciences or related science/engineering background with a strong emphasis in biologics/biopharmaceuticals
- Fluent in Chinese & English (verbal and written)
- Minimum of 10 years of relevant industry experience in quality & regulatory, CMC, process development and process validation related to biopharmaceutical products
- Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, Upstream and downstream process
- Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture
- Experience working in a global, matrix environment
- Able and willing to travel
Desired Qualifications
- Strong organizational and time management skills
- Good project management skills
- Ability to train and educate others
- Effective management by influence
- Ability to work in multi-cultural teams
- Good listening skills with the ability to analyze and respond to given situations quickly and effectively
- Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels
- Ability to indirectly influence other organizations and cultures
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project)
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