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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.
Full Time
Hospital
$157k-209k (estimate)
01/11/2024
05/26/2024
sparktx.com
PHILADELPHIA, PA
200 - 500
2013
Private
ELIZABETH JOHNSTON
$50M - $200M
Hospital
Spark Therapeutics develops gene therapies for the treatment of hemophilia and neurodegenerative diseases.
The following is the career advancement route for Director Regulatory CMC positions, which can be used as a reference in future career path planning. As a Director Regulatory CMC, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director Regulatory CMC. You can explore the career advancement for a Director Regulatory CMC below and select your interested title to get hiring information.