A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Preferred location: Shanghai or Beijing
The candidate will be a key regulatory expert for the portfolio of Life Science, consisting of single use, filter, consumable and process materials for the biopharmaceutical industry, as well as the portfolio of food and beverage. The candidate should have an understanding of regulations relevant to sterile drug, biopharmaceutical, food and beverage. In addition, the candidate must be well-versed in regulatory trends relevant to Life Science products.
- Take active role to build regulatory intelligence for Life Science. Focused area includes Single Use, Aseptic Processing, Virus Validation, process materials, microbiological and analytical test.
- 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
- in 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 APAC.
- 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 Science regulatory subject matter experts to link the local advocacy activities with global advocacy activities.
- Monitor competitor approach regarding regulatory requirements.
Education and Languages:
- Master / Ph.D. in life sciences or related science/engineering background with a strong emphasis in biologics.
- Fluent in Chinese & English (verbal and written) is required.
Who you are:
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 CFDA drug regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)
- Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic processing and validation procedures.
- Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell, gene 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
Functional Area: Regulatory and Medical Affairs
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.