RA Specialist

RA Specialist
Responsible for the writing and coordination of all CMC related documents/sections of regulatory submission such as IND, IMPD, briefing package of meetings with FDA/EMA, submission of variation.
Requirements:
At least 2 years experienced in RA (Biologics and FDA or EMA)
At least a master degree in Biology or Biochemistry
High regulatory writing skill
Experienced with handling CMC questions from FDA or EMA
Experienced in writing IND or BLA/MAA
Team player with high communication skills and positive personality