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Regulatory CMC Lead

Date: Mar 17, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

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.

 

We don’t follow footsteps. We create the path.

Summary

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

50%

  • 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

30%

  • Design, develop, and implement submission shell documents and best practices for CTD quality modules to streamline preparation of CMC submission content

10%

  • Create and maintain CMC core dossier to support consistent global submissions

10%

  • Serve as an integral member of cross-functional CMC team(s) and provide regulatory CMC leadership for assigned product(s). Provide robust regulatory guidance and support, both strategically and operationally, to the CMC Team(s) and regulatory team(s)

Qualifications

  • 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

Requirements

• BS in Biological Science required, MS in Biological Science preferred (e.g. Virology, Molecular Biology, Immunology, Cell Biology. Biology), with 5-8 years of relevant experience or a PhD with 4-6 years of relevant experience 

• Must have demonstrated expertise in technical writing related to CMC submissions, typically  gained through 4+ years of relevant experience

• Sound understanding of molecular biology and cell culture. 

• Experience in viral vaccine or viral vector gene therapy manufacturing is a plus


Nearest Major Market: Philadelphia

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