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
- 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)
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.