Regulatory Publishing Specialist
San Diego Metro Area, CA
1. Support Regulatory Affairs personnel in the coordination, preparation, and submission of all INDS/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format. Strong experience with submitting eCTD for Australia (AU) Region.
Responsible for the creation and compilation of quality Regulatory submissions and lifecycle management submissions. Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats. Maintain day-to-day operations of a large paper and electronic archive.
2. Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into RA file room and electronic document management system) within specified time frames.
3. Electronic Document Publishing (i.e., scanning, bookmarking/linking, and document verification,)
4. Verification of regulated documents via workflows within electronic document management system (eSub).
5. Adherence to required submission timelines, complex publishing, and archiving of regulated documents.
6. Liaise with functional source areas (clinical, nonclinical, cmc, 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
7. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the TGA, FDA and ICH.
8. May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
9. Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
10. Close interaction with authoring community to track availability of deliverables.
11. Other responsibilities related to the above, as assigned.
o BA/BS Degree, 2 yrs. pharmaceutical industry experience, prior Regulatory Operations experience preferred
o MUST HAVE - Looking for candidates with experience in Australia eCTD Submissions.
o Knowledge of TGA procedures/guidance s regarding electronic submissions for AU Region
o Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
o Technical knowledge of electronic publishing systems and software
o Proficiency with MS-Office Suite and Adobe Acrobat applications
o Knowledge of Electronic Document Management Systems
o Self-starter with superior time management skills, and ability to work independently or in teams
o Strong attention to detail"