Regulatory Specialist
Regulatory Specialist
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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.
Officebased in Taipei
Your role:
REGULATORY AFFAIRS
- Develop reasonable project timelines (regulatory and ethics committee aspects).
- Liaise with project team to procure documents necessary for regulatory and IRB submissions with review to ensure meeting local requirements.
- Prepare submission dossiers (coordinating translations & proofreading compiling the dossier) within planned timelines and submit to the authority and ethics committee.
- Prepare applications for import and export licenses where applicable.
- Review investigational product releaseenabling documents.
- Maintain regulatory study lifecycle manage changes in the study as applicable (by means of submitting notifications/supplemental applications).
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests.
SAFETY MANAGEMENT
- Manage safety reporting to authorities
Qualifications :
- University degree or an equivalent combination of education training and experience
- 23 years experience with clinical trial submissions in Taiwan (TFDA & EC)
- Full working proficiency in English and Chinese
- Proficiency in MS Office applications
- Ability to learn plan and work in a dynamic team environment
- Communication collaboration and problemsolving skills
- Knowledge of ICHGCP guidelines and local regulatory requirements
- Experience in preparing and reviewing regulatory submission documents
- Strong organizational skills and ability to manage multiple projects simultaneously
- Excellent time management skills to meet tight deadlines
- Ability to interpret and apply complex regulatory guidelines
- Willingness to stay updated on changing regulations and industry trends
Additional Information :
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
