Electronic Publishing - Regulatory Specialist
San Diego Metro Area, CA
Knowledge of IND, NDA, MAA, CTD requirements and guidelines; both paper and electronic required.
Must have experience working in Electronic Document Management Systems (EDMS).
Experience publishing eCTD using electronic publishing system and tools.
Knowledge of industry trends regarding electronic submissions.
Proficiency with MS-Office Suite and Adobe Acrobat application.
Ability to balance multiple tasks to meet priorities and timelines.
Self-starter with superior time management skills, and ability to work independently and in teams.
Attention to details.
Responsibilities will include, but are not limited to, the following:
Support Regulatory Affairs personnel in the coordination, preparation, and submission of all INDS/NDAs/MAAs and life cycle management of these submissions using EDMS and electronic publishing systems.
Responsible for planning, compiling, tracking, dispatching, and archiving regulatory documents and submissions in both paper, eCTD, and other electronic format.
Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, DSURs, PIPs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, Briefing Books, etc.
Technical verification of regulated documents via workflows within electronic document management systems.
Liaise with functional source areas (clinical, nonclinical, quality, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
Adherence to required submission timelines, health authority publishing specifications, and internal working practices.