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Regulatory Affairs Specialist

2 months ago

Shanghai, Shanghai, China PSI Full time

Job Title: Regulatory Officer

Job Summary:

We are seeking a highly skilled Regulatory Officer to join our team at PSI. As a Regulatory Officer, you will play a critical role in facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

Key Responsibilities:

Regulatory Intelligence:

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

Regulatory Affairs:

  • Develop project timelines (regulatory aspects)
  • Liaise with project teams to procure documents necessary for regulatory submissions, with review to ensure meeting local registration requirements
  • 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 the 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 the 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 as 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)

Additional Information: