技术法规经理

Posted 06 Jan 2023

Shanghai, Shanghai - China

Req Id 259380

 

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.

 


Your role:

The Role is within the Field Technology Management team. The candidate will serve as an experienced technical expert 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 solid working knowledge of biotechnology manufacturing principles (preferably CGT).

Essential Job Responsibilities:

  • Act as the technical expert in the Contract Testing Service (CTS) China team, providing scientific and technical support in line with the 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/coordinate 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 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 relevant 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
  • Advanced presentation skills and ability to effectively communicate complex 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
  • Monitor industry trends to ensure that BioReliance services remain at the forefront of scientific advancements in the field of Biologics; review and recommend potential technical developments to wider business.

 

HR: 89829

Functional Area: Commercial

 



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!


Equal Employment Opportunities

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.

North America Disclosure

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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