Regulatory Affairs Specialist

4 weeks ago

Shanghai, Shanghai, China PSI Full time

Company Overview

PSI is a leading provider of regulatory and ethics submissions for clinical studies.

Salary

$120,000 - $180,000 per annum, depending on experience.

Job Description

This role involves facilitating the start of research projects for novel medicinal products while taking a step further in your professional career.

Your Role:

Regulatory Intelligence

  • Monitor new regulations/guidelines and notify timely about changes.
  • Prepare newsletters on new regulations/guidelines.
  • Maintain internal regulatory library.
  • Build networks with regulatory authorities and industry.

Regulatory Affairs

  • Develop reasonable project timelines (regulatory aspects).
  • Liaise with project team to procure documents necessary for regulatory submissions, ensuring local registration requirements are met.
  • Prepare submission dossiers (coordinating translations & proofreading, compiling the dossier) within planned timelines and submit to the authority.
  • Coordinate registration of review fee payment, if necessary.
  • Maintain project documentations.
  • Track review progress by the authority and update status, respond to queries/deficiency letters.
  • Maintain regulatory study lifecycle, manage changes in the study as applicable (by means of submitting notifications/supplemental applications).
  • Arrange for procurement of Import License and IMP importation.

Safety Management

  • Prepare documents for notification/reporting of SUSARs & DSURs, and submit to the authority as per applicable regulatory requirements and bylaws.
  • Coordinate responses to queries by the authority on submitted SUSARs & DSURs.

Other

  • Handle HGR application.
  • Register/update clinical trial status on ChinaDrugTrials platform.

Qualifications

  • Bachelor's degree or above in Pharmacy, Medicine, Life Sciences, or related discipline.
  • At least 3 years of relevant RA experience. IND submission experience is a plus.
  • Knowledge of registration regulations and procedures in NMPA, CDE, NIFDC, HGRAC, and ICH guidelines.
  • Fluent written and oral communication skills in English.
  • Strong sense of responsibility, teamwork, and work quality.
  • Fast learning capability.
  • Proficiency in Microsoft Office (Word, Excel, PPT).

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