Director, Regulatory CMC

Role Summary

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.

Responsibilities

• Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects
• Develops CMC regulatory strategies to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities
• Provides strategic guidance on global regulatory CMC requirements to management and project teams
• Provides guidance to senior management and departments within CMC areas on all regulatory issues for the strategic development, planning, compilation and submission of assigned IND/CTA/MAA/NDA/BLA
• May represent the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration
• Manages preparation of assigned regulatory submissions (IND/CTA/MAA/NDA/BLA)
• Reviews and approves reports intended for use in regulatory submissions
• Actively engages with stakeholder groups to help shape science based regulatory decision making
• Acts as regulatory CMC liaison with partner companies and contract manufacturers
• Provides expertise in translating regulatory requirements into practical, workable plans
• Interacts with regulatory agencies for assigned projects
• Selects, develops and evaluates personnel to ensure the efficient operation of the function
• Other duties as assigned

Qualifications

• BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry. Prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, biologics, and/or gene therapies. Leadership experience in preparation and preferably, negotiation to marketing approval in major markets is desired. OR
• Master's degree preferred AND 10+ years similar experience noted above OR
• PhD preferred AND 7+ years similar experience noted above OR
• Extensive previous managerial experiences also required
• Acts as a "trusted advisor" across the company and may be recognized as an external expert
• Provides strategy, vision and direction regarding issues that may have company-wide impact
• Requires in-depth knowledge of the functional area, business strategies, and the company’s goals
• Possesses industry-leading knowledge
• Ability to apply advanced analytical thought and judgment
• Strong leadership, coaching, employee development skills
• Ability to influence others with or without authority at all levels of the organization
• Proactive, innovative, with excellent problem-solving skills
• Ability to work in a cross functional team and matrix environment
• Excellent written, presentation, and verbal communication skills
• Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies
• Detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA
• Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets