法规专家

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.  

Preferred location: Shanghai

The candidate will be a key regulatory expert for the portfolio of Process Solutions, Life Science Services and Science and Lab Solutions, and collaborate with other regulatory experts and SMEs to deliver advocacy initiatives. The candidate should have an understanding of regulations relevant to sterile drug manufacturing, and biopharmaceutical processing (upstream, downstream). In addition, the candidate must be well-versed in regulatory trends for pharma industry, aligned with the strategy of Life Science to build regulatory expertise relevant to Biopharmaceutical cGMPs.

Key Job Responsibilities:

• Take active role to build regulatory intelligence for Merck Life Science, e.g. mAb, vaccines, ADC, CGT, and new technology such as continue manufacture.
• Lead/Drive the China advocacy initiatives with clear progress, and posts in EVA or new media on dynamic advocacy and surveillance.
• Lead/Drive regulatory selling initiatives for LS portfolios.
• 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 in important regulatory bodies and industry associations, and internal stakeholders.
• Effective coordination of strategic activities of Life Science subject matter experts in local regulatory bodies and industry associations.
• Secure flow of information from/to authorities, industry associations and Life Science organization.
• 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.
• Provide relevant training to local Life Science marketing/sales colleagues about new regulatory trends and developments that drive our value proposition.
• Definition of processes to implement upcoming regulatory needs and requirements.
• Support regulatory expertise and consultation for customer regulatory inquiries.
• 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.

Education and Languages:

• Bachelor in life sciences or related science/engineering background with a strong emphasis in biologics.
• Fluent in Chinese & English (verbal and written) is required.

Professional Skills and Experiences:

• Minimum of 10 years of relevant industry experience and/or regulatory affairs related to biopharmaceutical products, pharmaceutical substances and process materials.
• Knowledgeable of NMPA drug regulations and regulatory landscape of other important country/regions (e.g. China, Japan, South Korea, EU, US)
• Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic process and validation procedures.
• Knowledge of regulations for Advanced Therapy.
• 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.
• Some experience in thought leadership.
• 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 frequently.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!