Apex Systems, Inc.
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.
Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into RA file room and electronic document management Electronic Document Publishing (i.e., scanning, bookmarking/linking, and document verification,)
Verification of regulated documents via workflows within electronic document management system (eSub).
Adherence to required submission timelines, complex publishing, and archiving of regulated documents.
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”
Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the TGA, FDA and ICH.
May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
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.
Close interaction with authoring community to track availability of deliverables.
Other responsibilities related to the above within the company as a whole, as assigned.
BA/BS Degree, 2 yrs. pharmaceutical industry experience, prior Regulatory Operations experience preferred
MUST HAVE - Looking for candidates with experience in Australia eCTD Submissions.
Knowledge of TGA procedures/guidance’s regarding electronic submissions for AU Region
Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
Technical knowledge of electronic publishing systems and software
Proficiency with MS-Office Suite and Adobe Acrobat applications
Knowledge of Electronic Document Management Systems
Self-starter with superior time management skills, and ability to work independently or in teams
Strong attention to detail
For immediate consideration, please send resumes to: firstname.lastname@example.org
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com
VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.
See all San Diego, Ca Jobs »