We are seeking an experienced GMP Consultant with prior MFDS reviewer or inspector experience to support a global biopharmaceutical project. This is a part-time, remote contract role, ideal for a senior professional looking to contribute expertise on a flexible basis.

Key Responsibilities:

• Provide expert GMP guidance to support regulatory strategy and compliance.

• Review GMP documentation and advise on best practices.

• Communicate effectively in Korean and English with stakeholders.

• Offer ad-hoc consulting support (estimated ~5 hours per month through December).
  
  Requirements:

• Previous role as an MFDS reviewer or inspector (nonclinical preferred).

• Extensive GMP expertise across biopharmaceuticals, sterile manufacturing, or related areas.

• Strong knowledge of Korean and international GMP regulations (FDA/EMA experience a plus).

• Fluent in Korean and English (written and spoken).

• Based in South Korea or able to work effectively in Korean time zone.
  
  Details:

• Start date: ASAP

• Fully remote role
  
  If you are interested, please share your CV and availability for a short call to discuss further.