Regulatory Specialist
Regulatory Specialist
Posted on :
20-12-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
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 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
- Review documents to greenlight IP release to sites
- 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
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
