CMC Regulatory Affairs Specialist

Company Description

ELGAN Pharma is a neonatology-focused biotechnology company dedicated to developing safe and tailored therapies to address medical problems and developmental difficulties common in babies born prematurely, specifically extremely low gestational age newborns. As the number one cause of newborn deaths, premature birth accentuates the need to improve healthcare and quality of life in this population. Our mission is to improve health outcomes for ELGANs by conducting meaningful scientific research with the hope of making a demonstrable difference in the lives of these vulnerable infants.

Role Description

The CMC Specialist is responsible for supporting the development, preparation, and maintenance of Chemistry, Manufacturing, and Controls (CMC) documentation for global regulatory submissions, including INDs, IMPDs, NDAs, and MAAs. This role involves close collaboration with cross-functional teams, including Manufacturing, Quality, Regulatory Affairs, and Analytical Development, to ensure the accuracy, consistency, and compliance of CMC data and documentation throughout the product lifecycle.

Qualifications

• Knowledge and experience in CMC Regulatory Affairs is a must
• Regulatory Compliance and Regulatory Requirements knowledge and experience
• Expertise in Regulatory Affairs and experience with regulatory submissions including NDA, IND, BLA, and CTA
• Knowledge and experience in medical writing is a plus
• Bachelor's degree or higher in chemistry, biology, pharmacy, or a related field; Master's degree preferred
• Strong communication, analytical, and leadership skills
• Ability to lead a project team and manage multiple priorities
• Organizational skills and attention to detail