Remote Regulatory Affairs Manager

Job Summary

A biotechnology research company is filling a position for a Remote Regulatory Affairs Manager.

Individual must be able to fulfill the following responsibilities:

• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions
• Ensure regulatory submissions are maintained in compliance with regulatory requirements
• Implement and maintain current regulatory knowledge and advise management of significant developments

Qualifications Include:

• Minimum of 3-5 years work experience in Regulatory Affairs
• Experience and knowledge in preparation of INDs (required) and NDAs (desirable)
• Experience with CTD/eCTD and understanding of FDA structure and function
• Experience with publishing documents in Adobe Acrobat Professional
• Working knowledge of FDA and ICH regulatory guidance and regulations
• Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle