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Sr. Regulatory Affairs Specialist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Apr 29, 2023

View more

Discipline
Other, Legal/Regulatory Affairs
Organization Type
Pharma

Job Details

Primary Duties

The Sr. Regulatory Affairs Specialist, under general guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA, EMA and other health authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include initial IND’s, CTA’s, Briefing documents, amendments, supplements, annual reports, DSURs and additional documents as needed. Compiles and reviews amendments, supplements, annual reports, etc., for FDA and other health authority submissions. Interacts effectively with cross functional team members in order to coordinate documentation required for submissions, ensuring that timelines are met.

Responsibilities

  • Leads regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
  • Interact with functional groups across the organization in the development of relevant data to complete regulatory submissions.
  • Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
  • Coordinate activities to maintain regulatory filings including planning and preparing annual reports, DSURs for INDs, CTA, etc.
  • Support the development of regulatory processes to manage developmental and post-approval compliance activities.
  • Support the development of regulatory processes for submission planning and management.
Other projects and duties may be required.

Education and Experience Requirements

  • BS in a scientific discipline or equivalent education, advanced degree preferred
  • Minimum 2-5 years experience in a Regulatory Affairs pharmaceutical or related environment preferred.
  • Working knowledge of all FDA requirements pertaining to submission of regulatory documents
  • Demonstrated ability to coordinate submissions independently in a time intensive situation
  • Experience on post-approval BLA maintenance and/or IND experience preferred

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.

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.


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.

Learn more about Spark Therapeutics and view other openings.

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.

Company info
Website

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