Job Description

General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into a marketed cell and gene therapy product.

Key Duties and Responsibilities:

• Oversees the preparation and review of CMC sections of regulatory submissions, and supports the interactions and responses with regulatory agencies
• Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product
• Leads and collaborates with individuals within Regulatory CMC to ensure robust and aligned CMC regulatory guidance is provided to cross-functional teams and stakeholders.
• Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area

Knowledge and Skills:

• Excellent interpersonal skills to influence others internally and/or externally and to negotiate with others
• 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
• Strong experience managing technical individuals in a matrixed environment

Education and Experience:

• Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, or another life-science field
• Requires 10 years of experience in the pharmaceutical or biotech industry or in a related field or the equivalent combination of education and experience. Cell and gene therapy experience is a plus.

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-EE1 #LI-Hybrid

Company Information