Ref #: 32844

Employment type: Fixed term - Full-Time

Location: Taipei, Taiwan - Office base

Posted: 07-Oct-2021


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.

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

Key responsibilities
1. Register new drug product licenses (NCE, line extension or generic products)
2. Drug product license maintenance for existing products
3. Follow local HA & headquarters/regional regulations timely to update product related changes
4. PMF registration and GMP follow-up renew
5. Submit PSUR regularly and update internal data base timely
6. Regulatory and documentation support for other franchise e.g. Market Access, KAM, Market­ ing, promotion materials review
7. Well-handle the assigned cases on track and be able to prevent and overcome the registration hurdles.

Required experience and qualifications
• Education: Bachelor degree or above, major in pharmacy or medical science related fields.
• Language: TOEIC score > 850 or English relevant certification, excellent command of written and spoken English
• Experience: 1-2 years of experience in Drug regulatory affairs i.e. drug product license maintenance and PMF/DMF registration etc.
• Better to have practically working experiences for drug product license maintenance including CMC variations, production transfer, product information update, and/or license renewal.
• TFDA work experience is very welcome to apply.

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.