Deepthi Deepthi Email & Phone Number

New Brunswick, Nj, Us

Prepared, compiled and reviewed global regulatory submissions and timely reporting to the manager and sending deliverable to FDA prior to deadline to obtain product approvalAssisted with cGMP/GMP documentationMaintained ongoing clinical research site filesReviewed clinical research dataTracked status of regulatory submissionsCorresponded to internal and external customer regulatory requestsPrepared, reviewed and evaluated SOPs Assisted with eCTD submissionsDeveloped and maintained regulatory affairs department procedures and product approvalsEffectively communicate project expectations to team members and stakeholders in a timely and clear fashionReviewed regulatory documents required for completeness and compliance with applicable regulations from the initial submission to close out of the research studies

Monmouth Junction, New Jersey, Us

Create, format, assemble, and to publish electronic submissions to the USFDA, including but not limited to IND, NDA, Clinical Study Report, CRF processing, Clinical Trial Applications, Protocol amendments, New-investigators, Annual Report, PADER, Meeting Requests, DSUR using FDA Guidelines.Editing internal and external hyperlinks and bookmarks for PDF files using Adobe Pro features and MedXview eCentral.Collaborates with the business to prepare and submit the required premarket submissions (e.g. PMA, 510(k), etc.)Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated productsCaptured data related to regulatory submissions like IND, NDA, BLA, 510(K), and PMA.

In

Created and maintained professional working relationship with team members and othersParticipated in cross functional team members meetings for improvements in regulatory department and maintain knowledge of current trends in pharmaceutical industryConveyed the regulatory information to other project team and provided input or update opinions as a core team memberAcquainted with drug and biologic regulations including IND, NDA/ANDA, BLA submissions, GxP's, 21 CFR, CAPA and Annual ReportsOn-regular basis submitting safety reports to health authorities like US and CanadaRepresent Regulatory Operations on project teams, driving timelines and deliverables related to submission documentsArchive certain submissions in Documentum based electronic document management systemsAssist in the estimation of publishing efforts needed to achieve and monitor the progress of assigned tasks