Regulatory Officer

2 weeks ago

Shanghai, Shanghai, China PSI Full time

Job Description

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

Office-based in Shanghai Office

Your role:

REGULATORY INTELLIGENCE

Monitor new regulations/guidelines and notify timely about the changes Prepare newsletter of new regulations/guidelines Maintain internal regulatory library Build up networks with the regulatory authorities and industry

REGULATORY AFFAIRS

Develop reasonable project timelines (regulatory aspects) Liaise with project team 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 the 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)

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