Regulatory Affairs Manager

Highly Competitive
  1. Permanent
  2. Project Manager
  3. China
Shanghai
Posting date: 01 May 2019
RA.SX.23048_1556709659

A clinical Contract Research Organisation (CRO) that provides high-end services to innovative biopharmaceutical and medical device companies is recruiting a Regulatory Affairs Manager. The organisation is committed to increasing the probability of success of R&D products. Based in the company's Shanghai office, this position is an exciting opportunity to work with an organisation whose services include Consulting, Clinical Operations, Biostatistics & Programming, and Quality Assurance.

Job Responsibilities:

  • Under the general direction of supervisor, assist and support supervisor for new and marketed products:
    • Develop regulatory affairs strategy and action plan.
    • Compile registration dossier and ensure timely regulatory submission upon internal review and approval.
    • Communicate with regulatory agencies/institutes (e.g., CFDA, CDE, NIFDC, Provincial Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
    • Timely /closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed.
    • Properly maintain all regulatory documentation.
  • Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets CFDA and internal requirements.
  • Maintain and develop good relationships with CFDA and other regulatory authorities (CDE, NICPBP, etc.) to facilitate and expedite regulatory approvals.
  • Maintain and update archiving system.
  • Collect relevant information of registration and administration of medicines in China, incl. generic status, legislation, updates to the registration requirements, guidelines etc.
  • Provide RA support to other functions and departments (e.g. R&D and Commercial etc).
  • Collaborate with HQ RA as required.

Skills and Requirements:

  • A university degree in a relevant field.
  • Previous experience in a similar or related capacity.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sara Xu at s.xu@proclinical.com or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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