Senior Regulatory & Quality Expert

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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 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:
Take active role to build regulatory intelligence for Life Science. Focused area includes upstream, downstream process, raw materials management and new technologies.
Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of business interests.
Safeguard LS strategic interests and objectives in arising guidance, standards and regulation.
Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business. Analyze available regulatory and compliance information.
Increases the influence of important regulatory bodies and industry associations.
Secure flow of information from/to authorities, industry associations.
Builds and keeps personal relationships to local and national authorities.
Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards.
Training for and support of internal stakeholders, external customers and relevant regulatory bodies.
Builds processes for the flow of information and regulatory intelligence within China.
Definition of processes to implement upcoming regulatory needs and requirements.
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.
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.
Monitor competitor approach regarding regulatory requirements.
Who you are:
Education and Languages:
Master/Ph.D. Life sciences or related science/engineering background with a strong emphasis in biologics/biopharmaceuticals.
Fluent in Chinese & English (verbal and written) is required.
Professional Skills and Experiences:
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.
Personal Skills and Competencies:
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).
Able and willing to travel.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!