Job Summary

A biotechnology company is in need of a Remote Senior Clinical Regulatory Affairs Director.

Individual must be able to fulfill the following responsibilities:

• Prepare and submit of IND and NDA packages
• Oversee preparation of regulatory documents

Required Skills:

• Experience preparing and submitting FDA meeting request, IND and NDA packages using the eCTD structure
• Exceptional communication, both verbal and written
• 5+ years in FDA regulatory affairs for the biotechnology and or supplement/cosmetic industry
• Experience and highly knowledgeable in the dermatology field