Senior Director/Director CMC Regulatory

Neurona Therapeutics is seeking a Senior Director / Director Regulatory CMC to lead regulatory CMC strategies for clinical development and commercialization. The ideal candidate has experience in cell and gene therapy product development, regulatory CMC leadership, and global filing experience. The candidate will join a newly formed Regulatory Affairs (RA) team and report to the senior vice president of RA. The person will work in a matrix environment and lead authoring and reviewing of documents required for global regulatory submissions, in compliance with applicable regulations.

Position Duties and Responsibilities

• Provide strategic CMC regulatory leadership and expertise to develop and execute regulatory strategies for global development and registration.
• Identify and communicate regulatory risks and facilitate risk mitigation strategies.
• Leads health authority interactions for CMC specific issues.
• Leads the development, writing, reviewing, and editing of CMC related technical data for inclusion in Module 3 of the common technical document (CTD). This will include information from standard operating procedures (SOPs), batch records, stability protocols, manufacturing process development, validation reports, etc for the preparation of INDs, BLAs, IMPD sections, related Module 2 summaries (QOS), briefing documents, and any other regulatory submission documents needed to support regulatory meetings, marketing applications, and life cycle management.
• Leads and manages CMC regulatory changes throughout the product life cycle.
• Performs reviews of documents prepared by other team members for completeness, accuracy, structure and grammar.
• Interprets and analyzes data related to product characterization, manufacturing process, product and process control, analytical tests, and stability while interpreting and analyzing applicable tables, listings, figures.
• Attends cross-functional meetings and works closely with process development, manufacturing, analytical, quality, and regulatory affairs team members to communicate document-specific timelines to ensure deliverables are completed on-time.
• Other duties as assigned

Skills, Education and Experience Required

This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.

If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https : / / www.cisa.gov / be-cyber-smart / report-incident to learn how to report it.