Regulatory Submission Specialist

Taipei City
Permanent
Full-time

15 days ago

Company DescriptionWe are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.PSI's business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.Job DescriptionJoin 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 TaipeiYour 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 release-enabling 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
2-3 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 problem-solving skills
Knowledge of ICH-GCP 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 InformationIf 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.

PSI CRO

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