Regulatory CMC Lead

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 31, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Organization Type
Pharma

Job Details

Primary Duties

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

% 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

  • 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
Key Skills, Abilities, and 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

#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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert