Senior Director Regulatory Affairs Strategy Consultant

Reporting to the President & CEO, the successful candidate will be responsible for leading and advising regulatory staff on regulatory strategies and compliance activities for development programs, as well as future commercial activities.

Responsibilities:

• Management oversight of regulatory activities for assigned programs
• Assume lead role in developing and guiding regulatory strategies to support successful development programs and regulatory approvals
• Oversee the preparation of global regulatory development plans (RDPs) outlining strategic plans to achieve rapid gene therapy product development
• Ensure that all projects have a clearly defined regulatory pathway and milestones leading to successful filings and approvals
• Oversee the development and management of defining key regulatory timelines and regulatory critical path activities
• Supervise and provide guidance for all global health authority communications/ submissions
• Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
• Establish processes with Commercial and Legal to support reviews of promotional material and labeling activities to support future commercial products
• Communicate effectively with the senior management personnel (and external partners, where appropriate)

Requirements/Qualifications:

• BS or BA in a scientific discipline and/or equivalent experience; Advanced degree strongly desired with at least 10 years in Regulatory Affairs in the industry
• Must have experience in cell and gene therapy drug development
• Experience in preparing regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
• Previous experience in a senior regulatory role, including interactions with regulatory agencies (as lead regulatory representative) is desirable
• In-depth understanding of regulations and guidelines governing all phases of drug development (for both drugs and biologics)
• Excellent verbal and written communication skills including presentation skills
• Experience with electronic submission process desirable