Director, Regulatory CMC - Cell & Gene Therapy

About the position

The Director, Regulatory CMC leads a cross-functional team in the execution of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and marketed products.

Responsibilities

• Oversees the preparation and review of CMC sections of regulatory submissions, and leads the interactions and responses with regulatory agencies
• Leads the development of global CMC regulatory strategies for multiple investigational and/or marketed products
• Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area
• Ensures assigned projects are appropriately resourced and is accountable for the results of the team

Requirements

• Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
• Typically requires 10 years of experience in the pharmaceutical or biotech industry or in a related field and 3 years of supervisory/cross-functional management experience, or the equivalent combination of education and experience

Nice-to-haves

• Excellent interpersonal skills to influence others internally and/or externally and to negotiate with others in a limited capacity
• Advanced strategic thinking and problem-solving skills
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Comprehensive knowledge of regulatory (FDA, EMA, Health Canada and ICH) guidelines
• Experience with development and/or improvement of department processes/procedures
• Proven ability to impact and influence the decisions of a team and decision making committees

Benefits

• Medical, dental and vision benefits
• Generous paid time off including a week-long company shutdown in the Summer and the Winter
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k)
• Annual bonus and annual equity awards