技术法规经理

Posted 25 Apr 2022

Shanghai, Shanghai - China

Req Id 246191

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 


Your role:

The Role is within the Field Technology Management team. The candidate will serve as an expert of technical authority in biological safety testing of biologics (preferably CGT) and vaccines for biopharma and biotechnology companies. For this expert-level technical position, it would be an advantage to have a proven of solid understanding of biotechnology manufacturing principles (preferably CGT).

Essential Job Responsibilities:

  • Act as the technical authority in the Contract Testing Service (CTS) China team, provides scientific and technical support in line with regulatory expectation to the drug development customers in China, preferably Cell & Gene Therapy (CGT) market
  • Support the Account Manager (AM) team to win new orders by leading and coordinating the scientific and technical communication between BioReliance and Clients in China
  • Draft customized testing services proposals, lead all related communications both internally and externally
  • Support AM and Operation team for troubleshooting by providing scientific knowledge and regulatory insights to our clients
  • Interact proactively with the global operation teams (China, UK, and US) to support the China Commercial team (AM team and project management team) to promote customer-first perspective and a culture of continuous improvement to the clients in China.
  • Close communication with global team of BioReliance to ensure all teams have an accurate and up-to-date understanding of the technique and regulatory requirements of clients in China.

Who you are:

  • M.Sc. degree. In Life Sciences or a relevant scientific field
  • Extensive experience in the pharma/biotechnology field, at least 2 years of proven experience in biologics and/or vaccines manufacturing and/or analytical assay development and applications
  • Prior experience of working in a Process Development, Quality Control, Regulatory or manufacturing environment of vaccines/biologics
  • Good understanding of regulatory affaires
  • Sophisticated presentation skills and ability to effectively communicate sophisticated technical/scientific topics both internally and externally.
  • Good verbal and written communication and presentation skills in English.

Preferred requirements:

  • Prior experience in regulatory affairs, involved in IND/NDA filing and submissions.
  • Ability to interact effectively with regulatory agencies
  • Supervise industry trends to ensure that BioReliance services remain at the forefront of advancements in the field of Biologics; review and recommend potential technical developments to wider business.

 

HR: 89829

Functional Area: Commercial


 

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

 

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