Multiple Regulatory Affairs Positions
GENSCIENCE PHARMACEUTICALS CO., LTD. (GENSCI), one of the largest biopharmaceutical companies in China focused on developing, manufacturing and marketing biologic therapeutics, has been ranked No. 1 for its profitability among Chinese biotech companies. Based in Changchun, China, GenSci's major products include recombinant human proteins such as growth hormones (rhGH), granulocyte colony stimulating factors (G-CSF), granulocyte macrophage colony stimulating factors (GM-CSF). Its Jintropin™ somatropin is the No. 1 rhGH brand with 70% of market share in China. For more information, visit www.gensci-china.com
As GenSci is rapidly expanding the global market, its department of international regulatory affairs is currently recruiting talented US professionals for several positions for international REGULATORY AFFAIRS (RA), including a Director or Manager, Senior RA Specialists, RA Associates or RA Assistants in areas of CMC, non-clinical and clinical trials.
We offer a stimulating working environment, a high level of professional and intellectual challenge, and attractive salaries and comprehensive benefits package depending on qualifications.
Duties and Responsibilities
Communicate with FDA, EMEA or other international government agencies as well as distributors in regard to registering GenSci's products in target counties
Draft or compile submission dossiers such as DMF in CTD format
Provide guidance for internal QA, QC to meet the regulatory requirements for target regions
Translate technical Chinese into English
Establish, propose or implement Regulatory Affairs strategies and tactics for biosimilar registration in EU or FOB in US.
Requirements and Qualifications
Chinese-English bilingual, ability to translate technical Chinese into English in areas such as biochemistry, pharmaceuticals, pharmacology or medical sciences
Experience or familiar with FDA or EMEA regulatory affairs
Experience or familiar with cGMP, WHO GMP and ICH guidance a plus.
Proactive, highly energetic team players
These positions require a minimum of a Bachelor's degree in scientific or healthcare disciplines, or equivalent combination of education and related experience. Education preferred is a M.S., Ph.D., R.Ph., or Pharm.D. degree or equivalent combination of education and related experience; RAPS RAC (U.S. or EU).
