Reporting to the Head of Regulatory CMC Strategy, the Regulatory CMC Lead will prepare high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management.
Responsibilities

In collaboration with regulatory leads and cross-functional CMC Teams, lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries. Incorporate regulatory strategy and well positioned content into high quality submissions to support successful outcomes

• Design, develop, and implement submission shell documents and best practices for CTD quality modules to streamline preparation of CMC submission content
• Create and maintain CMC core dossier to support consistent global submissions
• Serve as an integral member of cross-functional CMC team(s) and provide regulatory CMC leadership.  Develop regulatory strategies and timelines then execute to agreed plans.
• Routinely interact with multiple functional areas within Spark.
• Direct interaction with global health authorities.  Represent Spark Regulatory CMC at health authority meetings.

Education and Experience Requirements

• BS in Biological Science required, MS in Biological Science preferred (e.g. Virology, Molecular Biology, Immunology, Cell Biology. Biology), with 10+ years of relevant experience or a PhD with 4-6 years of relevant experience
• Must have demonstrated expertise in global, biologics regulatory CMC
• Sound understanding of molecular biology and cell culture.
• Experience in viral vaccine or viral vector gene therapy manufacturing is a plus
• Hybrid work arrangement; minimum 3 days on campus

Key Skills, Abilities, and Competencies

• Excellent written and communication skills and attention to detail
• Ability to work independently
• Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain
• Experience and knowledge in the preparation of electronic submissions
• Knowledge and understanding of US and ex-US regulations and ICH guidelines
• Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready
• Cross-functional team leadership skills

Complexity and Problem Solving

Represent Regulatory CMC on cross-functional governance meetings, provide regulatory guidance through those forums and execute according to project plans.