Associate Director, Regulatory Affairs CMC

The Associate Director, Regulatory Affairs CMC is responsible for ensuring company chemistry, manufacturing and control (CMC) strategies are developed and executed in compliance with established regulations, guidelines and industry standards.

Essential Duties and Responsibilities

• Responsible for regulatory strategy with regard to the Chemistry, Manufacturing and Control (CMC) of AGTC's products, participating in the development and implementation of regulatory strategies for AGTC's therapeutic programs from candidate selection through post-marketing support
• Collect, review and assemble CMC documentation for Regulatory Authority submissions (including routine correspondence, INDs, CTAs, BLAs, MAAs, Annual Reports, Amendments, Supplements, briefing packages, Orphan Drug Applications, etc.) with minimal oversight
• Responsible for CMC change management evaluation for AGTC's products and for providing guidance to inter-disciplinary project teams on product manufacturing and development approaches and regulatory submission requirements
• Liaise with regulatory authorities as directed to further product development programs and keep them in good standing
• Continue professional development by attending regulatory CMC-related meetings applicable to gene therapy products
• Assist in the maintenance of corporate quality systems in line with current GxP standards, regulations and company directives
• Aid in the implementation of infrastructure necessary for successful completion of product development (e.g., preparation of written procedures, review of departmental SOPs, establishment of electronic document standards)
• Other duties as assigned

Requirements

• BS degree in a scientific discipline, MS or PhD preferred
• At least 6 years' experience in Regulatory Affairs
• At least 4 years' experience supporting the manufacture and control of biologic drug products
• Direct experience assembling Regulatory applications in eCTD format
• Knowledge of FDA, ICH and EMA requirements for biopharmaceutical products
• Understanding/working knowledge of Microsoft Word and Excel
• Strong interpersonal, negotiating and problem-solving skills
• Excellent communication skills, both written and verbal
• Strong project management and organizational skills with ability to multi-task on several projects

Supervisory Responsibilities

This position does not have supervisory responsibilities