This is a new position based on growth. My client wants a person who is self-sufficient and wants to grow with this Public clinical stage Corporation located in Research Triangle Park, NC

The role of the Associate Director of Regulatory Affairs CMC will support regulatory CMC processes so that new chemical entities, dosage forms, and indications are registered and maintained in a compliant and timely fashion for this Public North Carolina Pharma Company.

Responsibilities:

• Coordinate the assembly and writing of CMC submissions in compliance with applicable ICH and FDA guidelines – provide guidance in project team meetings
• Summarize CMC data for regulatory submissions including INDs, NDAs and annual reports
• Ensure compliance with applicable industry standards, FDA, and global health authority regulations – provide guidance as needed
• Interact with regulatory authorities (FDA, EMA, etc.), and internal and external partners as needed

Requirements:

• Minimum BS in Scientific discipline
• 7-10+ years industry experience with at least 5 years in a Regulatory CMC function; global experience is highly desired
• Proven ability to successfully work cross functionally with different team leaders
• IND/NDA CMC experience
• Must be knowledgeable in preparing and reviewing CMC regulatory and/or CMC documentation
• Possess working knowledge of chemistry, analytics and pharmaceutical technology and of the drug development process
• Proven experience working with multinational project teams