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Job Location: Philadelphia, PA
The Regulatory Operations Specialist contributes to daily operations activities for preparation of regulatory submissions and collaborates with interdisciplinary teams and Regulatory Affairs staff in the management of submission components and tracking of deliverables. S/he is responsible for various aspects of publishing submissions and/or submission components. This includes operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, and production (paper and electronic), as applicable. The Regulatory Operations Specialist is also responsible for contributing to the development of standard processes related to regulatory submissions. This can include providing input for the revision of templates, and development of processes /procedures to ensure compliance with global regulations.
- Participates in the operational and logistical aspects of regulatory submission publishing ensuring quality and conformance to internal processes and global regulatory submission standards.
- Assures completeness and quality of NDA/IND/ eCTD, BLA, DMF and other types of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance.
- Works collaboratively with members of RA and other departments to define specifications regarding submission-related deliverables.
- Contributes to the update of working practices for processes used between departments using a lessons learned approach.
- Immediately raises issues for concern of potential business disruption or prioritization of resources.
- Participates in the evaluation and implementation of technology and equipment related to submission planning, preparation, assembly, dispatch, and/or archiving.
- Other projects and duties as may be required.
- Advanced skills in MS-Office, Adobe Acrobat applications, electronic document management systems.
- Excellent editing skills.
- Ability to handle multiple tasks and strong attention to detail.
- Hands-on experience and knowledge of IND/BLA/eCTD applications and other ICH/FDA electronic requirements and guidelines.
- Ability to work with strict deadlines, changing requirements and changing priorities.
- Excellent interpersonal, communication, and organizational skills.
- Successful performance in a high-intensity work environment.
- Experience in working with vendors in support of marketing authorization application submissions in and outside the USA.
- Advanced problem identification and problem solving skills; ability to exercise good judgment independently.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Bachelor's Degree in science related field plus 3+ years Regulatory Operations experience
- Associates Degree in science related field plus 5+ years Regulatory Operations experience, or equivalency of extensive experience in Regulatory.
WHO WE ARE:
Transforming Patients Lives.Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
How To Apply:
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