CAREER OPPORTUNITIES

COMPANY

Onegene Biotechnology is a biopharmaceutical company developing multi-targeting protein drugs for non-alcoholic steatohepatitis (NASH), fibrotic diseases, and cancers.
Our platform, UniStac, allows simultaneous targeting of three or more targets, thereby potentially providing transformative opportunities to cure patients suffering from chronic and complex diseases.

ROLE

Regulatory Affairs Specialist 

RESPONSIBILITIES

- Review manufacturing/quality data and write CTD documents for approval of IND for phase 1 clinical trial

- Prepares responses to regulatory agencies' questions and other correspondence as requested 

- Conduct meetings with regulatory agencies

- Develop IND regulatory strategy in global markets; U.S., EU, Australia, Mexico, Japan

QUALIFICATIONS

- Bachelor's degree required, Master's degree preferred 

- Degree within a technical related discipline is preferred; Pharmacy, Biology, Biotechnology, Life Science, Veterinary Medicine, or other equivalent background

- 5 ~ 10 years relevant experience in the Bio-pharmaceutical industry

- Ability to communicate effectively and proactively in English (in writing and speaking).

PREFERRED QUALIFICATIONS

- Experience in performing and managing global RA submissions and related activities is preferred.

- Experience in writing CTD Module 3 is preferred

Please send your resume and cover letter to: hr@onegenebt.com