Job Description

General Summary:

The Director, Regulatory CMC (Chemistry Manufacturing Controls) leads a cell therapy combination product program from development through commercialization through the execution of global regulatory CMC strategies for investigational and marketed 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.

Key Duties and 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 combination products, typically cell or gene therapy

• Leads and collaborates with individuals within Regulatory CMC to ensure robust and aligned CMC regulatory guidance is provided to cross-functional teams and key stakeholders

• Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area

Knowledge and Skills:

• Experience with medical devices, specifically combination products. Cell based experience is a plus.

  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

• Strong experience managing technical individuals

Education and Experience:

• 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, or the equivalent combination of education and experience.

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