与我们携手施展你的超能力！
探索未知、打破壁垒、勇于发现，你准备好了吗？你有宏图大志正待实现，我们同样雄心勃勃。我们遍布全球的员工热爱科技创新，以医药健康、生命科学和电子科技领域的解决方案，切实改善人类生活。我们怀揣远大梦想，热忱关爱员工、客户、患者和人类居住的这颗星球。因此我们一直在寻找永葆好奇心的你，与我们一路同行、敢想敢做，把不可能变为可能！
Job Title: Senior Regulatory Expert
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.
我们能够提供：我们对未知充满好奇，我们的员工有着多样化的背景、多维度的视角和个性化的经历。作为一家前沿科技企业，我们欣赏全方位的多元性，坚信这能驱动卓越和创新，从而强化我们“科技先锋”的底色。同时我们致力于为所有员工提供机会和资源，支持他们按各自的节奏充分成长和发展。加入我们，共建充满包容性和归属感的企业文化，让每一位志同道合的伙伴能够施展自己的超能力，共同推动人类迈向进步的未来!
立即申请，成为我们多元化团队的一员！