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 unlock the power of gene therapy to accelerate healthcare transformation.
We don't follow footsteps. We create the path.
Primary Duties
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
Education and Experience Requirements
Key Skills, Abilities, and Competencies
Complexity and Problem Solving
Represent Regulatory CMC on cross-functional governance meetings, provide regulatory guidance through those forums and execute according to project plans.
Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $187,100 to $280,700.
Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.