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.
% of Time Job Function and Description
40%In collaboration with regulatory leads and cross-functional CMC Teams, this role will 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
30%Create and maintain CMC core dossier to support consistent global submissions
20%Work with the Regulatory CMC team to design, develop, and implement submission shell documents and best practices for CTD quality modules to streamline preparation of CMC submission content
10%Participate on cross-functional CMC team(s) and provide regulatory CMC guidance for assigned product(s). Execute regulatory guidance and support as determined by the Regulatory CMC team, both strategically and operationally, through the CMC Team(s) and regulatory team(s)
Education and Experience Requirements
Key Skills, Abilities, and Competencies
- BS in Biological Science required, MS or PhD in Biological Science preferred (e.g. Virology, Molecular Biology, Immunology, Cell Biology. Biology)
- Minimum of 8 years of related experience or generally 5-8 years of relevant experience with a PhD (required experience will vary bases on education and expertise)
- Demonstrated expertise in global, biologics regulatory CMC
- Proven sound understanding of molecular biology and cell culture.
- Experience in viral vaccine or viral vector gene therapy manufacturing is a plus
- 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
- Excellent written and communication skills and attention to detail
- Ability to work independently
- Demonstrated strong organizational skills
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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