Nithya D Email & Phone Number

Jersey City, Nj, Us

Laval, Quebec, Ca

 Regulatory dossier specialist with 5 years of experience in handling regulatory dossiers to multiple Health Authorities. Triage and prioritize assigned projects to ensure timely and successful completion and alignment with business needs of external customers. Perform advanced formatting and review of scientific and regulatory documents for submission to FDA and global health organizations. Experience with NDAs, IND, ANDA, Annual Reports.  Use Submission management suite to update the dossier related attributes, collect all meta data, dossier documents, source links and submission dates. Build regulatory submissions for FDA and other global health authorities using current knowledge of advanced tools (Insight Publisher, viewer and validator) Review, proof and assemble eCTD compliant and paper regulatory submissions. Compile and publish regulatory submissions for assigned programs.  Coordinate printing, distribution of both paper and electronic submissions to all concerned markets within agreed upon timeframes.  Manage submission and product life-cycle information.  Provided Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/linking, and document verification) and compiled Module 1-5 in eCTD format, Paper or NeeS (where applicable). Proficient with Global regulatory compliance requirements including EU MDD, EU MDR, Canada, Brazil, China, Japan. Senior level experience in medical device development,, design verification, test protocols, fetal monitors, ultrasound scaners. Used multiple document management systems. Involved in the complete dossier management process and seeing the submission is delivered to the agency on the planned submission date. Ability to multitask to meet and aggressive time lines in regulatory submissions.  Good analytical, inter personal, problem solving, oral and written communication skills.  Maintained expert knowledge of internal and external publishing standards.

 Expert in using Liquent Insight Suite for submission management and for publishing submissions in eCTD, NeeS and paper format for different submission types. Collaborated with Regulatory Specialists for planning, preparation, publishing, and quality control checks of submissions. Perform advanced formatting and review of scientific and regulatory documents for submission to FDA and global health organizations. Experience with NDAs, IND, ANDA, BLA applications working on several submission types like Annual reports, Safeties, protocol amendments, promotional submissions and other lifecycle submissions including the original submission. Formatting and publishing of clinical study reports.  Formatted regulatory documents and managed document templates to assure the standards outlined by the authoring style guide were met. Develop EMC & Safety Certification test plans, Verification Procedures, and Reports Manage multiple projects and priorities defined by program or functional management. Interfaced with outside regulatory agencies and cross-functional departments Provided Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/linking, and document verification) and compiled Module 1-5 in eCTD format, Paper or NeeS (where applicable). Proficient with Global regulatory compliance requirements including EU MDD, EU MDR, Canada, Brazil, China, Japan. Assisted with activities associated with preparedness for future eCTD filings, i.e. business process documentation, system testing, validation, assisting with pilot submissions, etc. Maintained expert knowledge of internal and external publishing standards. Performed electronic publishing tasks including assembling submissions electronically using eCTD software and providing final output on paper and/or electronic format.

Mumbai, Maharashtra, In

Insight Publisher, Insight Validator, Insight for Viewing, ISIToolbox, Adobe Acrobat Pro, MS Office Suite, S-cubed eCTD publishing tool, eCTD reviewer, Documentum.

Ms In Pharmacy Administration, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Bachelor Of Pharmacy - Bpharm, Pharmacy