Regulatory Manager APAC

Posted 06 Dec 2018

Shanghai - all, Shanghai - China

Req Id 182878

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

  • 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 of 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 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:

  • 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.

Functional area: Regulatory & Medical Affairs


What we offer: 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!

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