Sr. Manager, Regulatory Affairs Cell and Gene Therapy

About This Role

This role involves interpreting and disseminating global regulations, guidelines, and emerging industry developments to influence pharmaceutical product development, specifically in cell and gene therapy. This position focuses on aligning regulatory tools with strategic objectives and managing regulatory professionals.

Responsibilities

• Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area of cell and gene therapy
• Lead maintenance and improvements to regulatory tools, including regulatory information systems to meet organizational objectives
• Provide regulatory expertise and support to business leadership
• Develop regulatory strategies accounting for global requirements and desired marketing claims
• Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other regulatory bodies
• Provide regulatory direction to product development teams
• Lead all aspects of regulatory compliance of advertising and promotional materials
• Supervise compliance with license registration, listing, and renewal requirements
• Provide leadership and guidance for the reporting and communicating of product-associated complaints, recalls, market withdrawals, and vigilance reports as applicable
• Direct the process for evaluating and processing product change requests including impact assessment
• Propose innovative regulatory options for new products or claims
• Manage departmental budget
• Determine work priorities aligned with business, functional, and company goals
• Lead a team of regulatory professionals
• Communicate a clear plan and motivate the team to achieve goals and defined success metrics

Requirements

• Extensive knowledge of regulatory requirements from the FDA, Health Canada, and other regions, particularly concerning pharmaceutical raw materials and cell and gene therapies
• Ability to evaluate and analyze potential regulatory impact on new and existing products and provide strategic recommendations
• Extensive experience in compiling and submitting regulatory filings with a track record of leading successful complex regulatory filings in relation to cell and gene therapies
• Demonstrated ability to navigate regulatory authorities' requirements and effectively communicate with them
• Excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams
• Advanced organizational and time management skills to efficiently prioritize and manage multiple complex projects simultaneously

Qualifications

• Bachelor's degree in life sciences, pharmacy, or related field required
• Minimum of 8 years related experience in the pharmaceutical or life sciences industry or an advanced degree with 6 years related experience

Nice to Have

• 2-4 years of people management experience

Benefits