The Sr. 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 submission components. This includes operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, and production (electronic and rarely paper), as applicable. The Sr. 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.
Leads 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 ofIND/ eCTD, BLA, MAA, DMF and other types ofsubmissions 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.
A minimum of an Associate degree or equivalent experience in Regulatory Operations.
- Advanced skills in eCTD Publishing tools, MS-Office, Adobe Acrobat applications, as well as Veeva Vault RIM.
- Excellent editing skills requiring advanced use of publishing tools, MS Word, pdf editing tools.
- Ability to handle multiple tasks and strong attention to detail.
- Hands-on experience and knowledge of IND/BLA/MAA eCTD applications and other ICH/FDA electronic requirements and guidelines.
- Hands-on experience and knowledge of Rest of World (ROW) non-eCTD submissions such as, but no limited to, Canadian and EU CTAs, and PIPs.
- 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.
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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.
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