Regulatory Specialist

SWATI CHITKARA

Email – *************@*****.***

Mo. +1-443-***-****

Professional Summary:

•2 years of experience in Regulatory Submissions.

•Worked extensively on submissions to IRB and Sponsors, site audits, internal audits, staff training.

•Experience on writing Protocols, Consent Documents, Source Documents.

•Extensively worked on Data Transcription.

•Experience in writing detailed Standard Operating Procedures.

•Extensively worked with Internal staff and Quality Management Team in analyzing performance issues and implementing Corrective Action Plans.

•Excellent communication, interpersonal & analytical skills with proven abilities in resolving complex Regulatory Compliance issues.

•Experience in coordinating projects with ability to pay attention to detail.

•Knowledge of Codes of Federal Regulation (CFRs), Good Clinical Practices (GCPs) Guidelines and Good Manufacturing Practice (GMP) Guidelines.

•Demonstrated ability to work in a team with independent problem solving skills.

•Demonstrated ability to work under strict deadlines with changing priorities.

Education

MS in Bioscience Regulatory Affairs

Johns Hopkins University, Baltimore, Maryland December 2009

BSc. Hons. in Biotechnology

University of Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom June 2008

Professional Membership: Society of Clinical Research Associates (SOCRA)

Honors and Awards

2005-2008: University of Newcastle upon Tyne and Study Overseas Pvt Ltd Joint Scholarship

Professional Experience

Job Title Regulatory Operations Coordinator

Company Human Research Protections Office, University of Maryland, Baltimore MD

Role

Review of Regulatory Submissions for Criteria of Approval and Regulatory Compliance, Coordinating IRB Meetings and post-meeting activities.

Duration February 2011 – Till Date

Responsibilities (With Skills)

1.Process IRB transactions for Human Subjects Research Determinations, Exempt categories, Expedited transactions, Emergency use and Humanitarian Use.

2.Coordinate IRB meetings and record meeting minutes.

3.Post-meeting activities for communicating review results to the research team.

4.Exercising the ability to analyze data and resolve issues.

5.Communicating efficiently and effectively both orally and in writing with a variety of people internal and external to the organization.

Job Title Regulatory Affairs Specialist

Company SNBL Clinical Pharmacology Center, Baltimore MD

Role

Prepared Regulatory Submissions to the IRB and sponsors, archived and maintained study specific Trial Master File Binders.

Duration March 2010 – February 2011

Responsibilities (With Skills)

1.Prepared and submitted study specific regulatory documents to IRBs for initial approval, continuing review, study closure, deviations, Unanticipated Problems and site approval.

2.Archiving of regulatory submissions, correspondence, and other applicable documents through departmental policies, procedures and tools.

3.Prepared for site initiation visits and monitor visits.

4.Prepared study specific source documents.

5.Data transcription to paper or electronic case report forms.

Job Title Quality Assurance Specialist

Company SNBL Clinical Pharmacology Center, Baltimore MD

Role

Performed Quality Assurance internal and vendor audits, provided regulatory compliance guidance and training to the internal staff,

Duration March 2010 – February 2011

Responsibilities (With Skills)

1.Conducted quality assurance audits of clinical trial data and records including online database and study files.

2.Performed Quality Assurance audits for internal departments and outside vendors.

3.Prepared for site qualification audits and sponsor audits.

4Prepared responses to audit reports.

5.Developed and revised the Standard Operating procedures.

6.Provided training to research staff on Standard Operating Procedures and Regulatory guidelines.

VOCATIONAL PLACEMENTS

Title Regulatory Intern

Company GlaxoSmith Kline, Delhi, India

Role

Reviewed Regulatory submissions to DCGI, study protocols, statements of sponsor and investigator, licenses for export of test materials. Extensively worked on interpretation of Asian Regulations.

Duration October 2008 – December 2008

Title Vocational Research Project

Company University of Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom

Role

Research project Title: Uptake and Regulation of amino acids by stressed intestinal epithelial cells.

Techniques practiced were cell culture, RNA and DNA extraction, PCR, Agarose gel electrophoresis, western blotting. Worked in coordination with other research groups to analyze the data and planning of the research experiment.

Duration June 2007 – August 2007

References: Available on request

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