Project Quality Control

Shweta Panchanan Burman

**************@*****.*** ● 129 Chiswick Road, #17, Brighton MA - 02135 ● Mobile: +1-857-***-****

WORK EXPERIENCE

M/s Fujifilm Pharmaceuticals, Cambridge MA USA

Document Coordinator Dec 2016 – Present

Responsible for correct sequencing, cataloging and locating files to their appropriate folders related with CMC, Preclinical, Clinical and Regulatory in company’s software database.

Deleting the duplicate files and moving the older versions of similar files to separate folder in order to distinguish with recent version.

Creating and naming the documents according to companies own name convention.

Focus on module 3 and 4 eCTD submission.

Responsible for IND filings.

Experience with TMF and CTA documentations.

M/s Boehringer Ingelheim

Regulatory Affairs Associate Jul 2015 – Jan 2016

Reviewed and assisted in e-CTD submissions, compiled NDA dossiers documentations with study team for specific drug which was antidiabetic type 2, jardiance.

Performed project on safety reporting’s by comparing from company core data sheet (CCDS) a global document with other package inserts like India, United States and Europe for a specific drug and establishing the difference among them as per its labelling conditions for empagliflozin (Jardiance) which is said to be type 2 antidiabetics.

Assisted, reviewed in IND, NDA preparation and submissions with project team to regulatory authority.

Review of safety assessment reports for USFDA, EMEA.

Coordinate and review documentation received from cross-functional team members for accuracy, completeness and to ensure compliance with applicable regulations and requirements.

Coordinated with cross functional department personnel from QA, QC, laboratory and manufacturing departments to gather documents in regards to submissions.

SOP training on site feasibility and selections, trail initiation visits followed by best practice sharing and cases studies, on- site monitoring, investigator site file, patient confidentiality, informed consent including guidance on audio visual recording of the ICF process

Review knowledge about database like BIRDS (Boehringer Ingelheim Regulatory Documentation Systems), CTMS (Clinical Trail Management Systems), and ISF (Investigator Site Files) and their coordinating their documentations.

Knowledge and assisting study team with identifying types of non-compliances, root cause investigations and analysis, application of CAPA, Deviations, Non -conformance plans to prevent the non-compliance in future and recording and calculating by key performance indicator known as KPI for quality control.

M/s Sanjivani Parenteral Ltd., India

Regulatory Affairs Associate Jul 2012 – Sep 2013

Review, preparation and compilation of IND, NDA.

Coordinated with cross functional department personnel from QA, QC, laboratory and manufacturing departments to gather documents.

Understanding of regulatory submission in eCTD format.

Assisted in maintenance of both the paper-based and electronic files of regulatory documents/submissions.

Review of form 144 import license form approval, and acknowledgement letters by DCGI.

Coordinate and review documentation received from cross-functional team members for accuracy, completeness and to ensure compliance with applicable regulations and requirements.

Assists in the RA review of labeling content and product documentation.

Understanding of schedule Y, form 44 a clinical trial application (CTA), clinical trial registry (CTRI).

EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices Apr 2016

SPTM NMIMS University Mumbai, India

Bachelor of Pharmacy Jul 201

ACADEMIC PROJECTS

Prepared and submitted 510(k) for class 2 device like surgical sutures, intravascular catheters.

Prepared and submitted Canadian License Submission for “AITOCSAVON Monitor” to Health Canada.

Preparation of Informed consent form and financial disclosure form.

IND application preparations and submissions.

Preparation of CAPA and validation reports.

Preparation of Biological License Application (BLA).

Preparation of Phase 1 clinical protocol synopsis.

Using Microsoft Project 2013 for Gantt chart preparations on preclinical and clinical studies.

SKILLS

Preparation, review and maintenance of regulatory dossiers in paper and eCTD format documentations.

Microsoft project 2013 preparation of Gantt charts, Adobe Acrobat, Excel, Word, PowerPoint, Outlook.

IND, NDA, PMA, IDE, 510(k), BLA, QSR (Quality system requirement) 820, ISO 13485, Combinational products, ICH guidelines, e-CTD submissions, Informed consent, IRB submission, DMFs, TMFs.

Inform consent, GCP, 21CFR 50, 54, 56, cGMP, GLP, labeling, documentations knowledge.

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