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Regulatory Affairs CMC Sr. Scientist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Closing date
Apr 22, 2022

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Job Details

Reporting to the Regulatory CMC Lead, the Regulatory CMC Senior Scientistwill prepare high quality chemistry, manufacturing, and controls (CMC) regulatory submissions to support global clinical development, registration, and product life cycle management.

Responsibilities:

In collaboration with Regulatory Strategy Leads and cross-functional CMC teams, support generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and responses to regulatory authority queries. Incorporate regulatory strategies and well positioned content into high quality submissions to support successful outcomes.

Support 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.

Maintain clinical trial applications and marketing applications according to regulatory requirements by preparing and submitting annual reports, distribution reports, routine reporting amendments. Support quality systems by reviewing and providing input to deviations, annual product reviews and assessing change controls for reportability to health authorities.

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)

Requirements:

  • BS in Life Sciences
  • 3 years of relevant experience
  • Proven strength in technical writing
  • Experience in biologicsand/or cell and gene therapy
  • Experience supporting regulatory submissions

Competencies:

  • 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
  • Experience with US and ex-US regulations and ICH guidelines
  • Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready

#LI-Hybrid

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.


Nearest Major Market: Philadelphia



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.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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