Ref #: 29455

Employment type: Permanent - Full-Time

Location: Taipei, Taiwan

Posted: 26-May-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a "Regulatory Affairs Specialist" to work closely with our client, a leading pharmaceutical company.


Overview
* Well-handle the assigned registration cases on track and able to prevent/overcome the registration hurdles.
* Product license maintenance for existing products


Key responsibilities
? Extending validity of existing product licenses i.e. CMC variations, IPL update etc.
? Follow local HA & headquarters/regional regulations timely to update product related chang-es
? PMF registration or GMP follow-up renew
? Submit PSUR & RMP regularly
? Regulatory and documentation support for other franchise e.g. Market Access, KAM, Mar-keting, promotion materials review
? DRAGON update timely
? Other assignments


Required experience and qualifications
- Bachelor degree or above, major in pharmacy or medical science related fields
- Excellent command of written and spoken English
- At least 1 year experience in regulatory affairs
- Register new drug product licenses is preferable


Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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