The Sr. Regulatory Operations Specialist contributes to daily operations activities for preparation of regulatory submissions to FDA, EMA, and other key health authorities. They also collaborate with Regulatory Affairs staff and interdisciplinary teams in the management of submission components and tracking of deliverables.
The Sr. Regulatory Operations Specialist is responsible for various aspects and publishing of regulatory submissions as well as the submission components. This includes, but is not limited to formatting of regulatory documents, readying documents for handoff to a publishing vendor and the publishing of submissions (both eCTD, paper, etc.), as applicable.
The Sr. Regulatory Operations Specialist is also responsible for contributing to the development and initiation of standard processes related to regulatory operations. This can include developing or revising templates, and developing processes/procedures to ensure compliance with global regulations. The Sr. Regulatory Operations Specialist interprets local and global submission regulations and applies that knowledge as needed.
50% of the time
•Support regulatory activities and coordinate filings (e.g. IND, amendments, BLAs, Supplements, CTAs, MAA) as appropriate
•Participates in the operational and logistical aspects of regulatory submissions ensuring quality and conformance to internal processes and global regulatory submission standards
•Assures completeness and quality of regulatory submissions from the operations perspective. Identifies issues, suggests, and implements solutions under guidance.
•Works collaboratively with members of other departments to define specifications regarding submission-related deliverables
•Manage deliverables and submission timelines to ensure on-time delivery to regional markets.
•Manage vendor interactions in conjunction with global submission handoffs, both major and lifecycle
30% of the time
•Contributes to the implementation of publishing systems, the development and implementation of training programs for submission-related software.
•Contributes to the development and implementation of processes related to global regulatory submissions, both major and lifecycle, for submission contributors.
•Contributes to the creation and update of working practices for processes used between departments using a lessons learned approach
•Works to increase efficiency with regard to regulatory operations and manage and implement those process improvements. This can involve developing future regulatory processes, standards and workflows as well as analyzing current ones, and ensuring compliance with regulations for the generation of electronic submission-ready documents
20% of the time
•Other projects and duties as may be required
•Bachelor's Degree in science related field preferred
•Minimum 5+ years of related hands-on experience; with extensive knowledge of all submission types and their related requirements and guidelines, including extensive knowledge of current ICH guidelines as they pertain to Regulatory Operations
•Experience working with vendors in support of all submission types to all major Health Authorities (FDA, EMA, HC, etc).
•Expert skills in MS-Office, Adobe Acrobat applications, electronic document management systems (Veeva Vault or equivalent), GlobalSubmit REVIEW and VALIDATE.
•Excellent document formatting/editing skills
•Ability to handle multiple tasks with a strong attention to detail.
•Excellent interpersonal communication and organizational skills.
•Successful performance in a high-intensity work environment.
•Ability to work with strict deadlines, and flexibility to work with changing requirements and priorities
•Ability to perform a wide range of tasks associated with Regulatory Operations
•Strong submission/project management skills
•Bachelor's Degree in science related field plus 5 years Regulatory Affairs Operations experience
WHO WE ARE:
Transforming Patient’s 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.