Regulatory Affairs and Clinical Trials

Rashmi Bist

408-***-**** (H) . 415-***-**** (M) . **********@*****.***

Qualifications Summary

Diligent and results-focused professional, highly motivated to leverage

advanced academic training and complementary experience to excel as

Regulatory Affairs Specialist.

. Regulatory Compliance: Possess extensive training and hands-on

experience in the coordination, preparation, and submission of

regulatory documents, including ANDA, annual reports, responses to

queries, and supplements. Well-versed in medical writing and review of

CTD Module 3 - CMC sections (batch records, specifications sheets, test

methods, validation reports, and stability data). Adept at providing

regulatory guidance to support cross-functional teams.

. Clinical Data Management: Expertise in the principles of Good Clinical

Practice (GCP) relevant to the roles and responsibilities of

Investigator, Sponsor, IRB, FDA, and the study subject. Knowledgeable

in the utilization of Electronic Data Capture (EDC) systems (Medidata -

Rave, Medrio, and Openclinical) for data management, and study

monitoring. Educated in clinical trial design and monitoring.

. Effective Communication: Strong written and verbal communication acumen

coupled with excellent interpersonal skills. Readily build and maintain

collaborative, productive working relationships with across functions,

disciplines, and organizational levels. Effectively partner with

colleagues across quality assurance, product development, and

manufacturing to obtain / provide information for regulatory

submission.

. Key Strengths: Detail-oriented with finely-tuned analytical skills;

deftly conduct regulatory research, identifying and interpreting

regulatory guidelines or revisions and ensuring they are accurately

communicated to product development teams. Proficient in Windows and

Microsoft Office with the ability to quickly learn and master new

software applications and database systems. Well-versed in FDA and ICH

guidelines.

Educational Background

Clinical Trials Design & Management Program Regulatory Affairs Program,

anticipated 2014

University of California, Santa Cruz, Sunnyvale, California

Master Degree, Pharmacy, 2001

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), New

Delhi, India

Graduated in Top 0.1% of Class

Completed Research Project through the National Institute of Immunology,

New Delhi:

Cloning, Expression, and Purification of M.Tuberculosis Culture Filtrate

Protein CFP6 for Immunological Evaluation Towards Development of Subunit

Vaccine.

Bachelor of Pharmacy Degree, Pharmaceutical Sciences, 1999

Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), New

Delhi, India

Registered Pharmacist, Delhi Pharmacy Council

Member, RAPS

Member, Indian Hospital Pharmacist Association

Professional Experience

University of California, Santa Cruz, Sunnyvale, California

Student (7/2012 - Present)

Concurrently pursing coursework in the Clinical Trials Design and

Management and Regulatory Affairs programs, studying the drug development

process, good clinical practices and good manufacturing practices,

clinical trial site monitoring, and the science of clinical trial design.

Complete research and assignments relevant to electronic data capture for

clinical trials and reporting of drug safety data and adverse events.

Practice medical writing and strategies for effective interaction with the

FDA. Acquire in-depth knowledge on the regulations of medical device and

diagnostics as well as regulatory submission of drugs and biologics.

Selected Contribution:

. Gained hands-on experience with EDC systems, assuming roles

as study coordinators, investigators, study monitors, and

data managers to perform EDC tasks.

. Prepared a regulatory binder comprised of guidance

documentation relevant to the CMC aspect of drugs and

biologics during IND, NDA / BLA, and post-approval stages.

. Conducted analysis of warning letters from FDA to clinical

Investigators; identified areas of deficiencies, FDA

expectations, and potential improvements.

. Completed a research paper on the Orphan Drug Act (ODA)

focused on incentives, risk of abuse and ambiguities,

success of the ODA, and emerging trends;

. Authored an opinion paper on regulations of "claims made

by drug representative to physicians."

Novartis Healthcare, Hyderabad, India

Senior Executive - Regulatory CMC (10/2006 - 10/2007)

Related Skills: Regulatory Compliance, Effective Communication, Cross-

functional Coordination, Regulatory Submission, Teamwork, Problem

Solving, Data Analysis, Team Training

Participated in strategic planning, evaluation, and assembly of regulatory

submissions in collaboration with product development, regulatory, and

manufacturing teams in Basel (Switzerland) and the United States; prepared

supplements, variation documents, amendments, and annual reports for

International health agencies. Served as trusted resource for project

teams, offering advice on regulatory compliance matters. Trained new staff

members on internal work system and electronic submission of documents.

Selected Contribution:

. Actively pursued completion and submission of annual

reports, maintaining up-to-date knowledge of changes in

regulatory guidelines and evaluating potential impacts on

regulatory filings and approval process.

Ranbaxy Research Labs, New Delhi, India

Research Scientist - International Drug Regulatory Affairs (1/2002 -

10/2006)

Related Skills: Regulatory Submissions, Cross-functional Collaboration,

Documentation & Reporting, Data Analysis / Verification, Regulatory

Compliance

Managed submission of Abbreviated New Drug Application (ANDA) with

International health agencies, including EMEA, TGA, Medsafe, and ANVISA;

coordinated with a multidisciplinary team to facilitate meetings, gather

required documentation aligned with prevailing regulatory requirements,

and verify completeness and accuracy. Completed submission process for

marketing authorization applications through the EU Mutual Recognition

Procedure (MRP) and Centralized Procedures; promptly completed post-

approval marketing authorization changes. Reviewed and responded to

product-specific inquiries related to national filings and MRP.

Selected Contribution:

. Provided essential regulatory guidance to support strategic

planning across all stages of product development, ensuring

regulatory compliance of under-development drugs upon

submission.

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