Reshmaraj Venkatraj

732-***-**** • actiim@r.postjobfree.com • Boston, MA 02115

Education

Northeastern University Boston, MA

Candidate for Master of Science in Regulatory Affairs for Drugs, Medical Devices and Biologics Apr 2015-Present

Relevant Coursework: New Drug Development, Biologics Development, Medical Device Development Managing International Clinical Trials, Advanced Writing in International Biomedical Topics, and Human Experimentation: Methodological Issues Fundamentals.

Anna University Chennai, India

Bachelor of Technology in Pharmaceutical Technology Aug 2010-May 2014

Relevant Coursework: Regulatory Issues and Drug Validation in a Pharmaceutical Company, Clinical Research CGPA 3.68/4

Skills

Quality management: Good documentation skills, Archiving of documents, GDP compliance

Computer Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Access), Adobe Acrobat Professional, and Basics of HTML, LINUX.

Guidelines: Knowledge of Clinical Development Phases. Well-versed in USFDA 21 CFR Part 11, 210 and 211 and guidelines of ICH E6 GCP.

Basic working knowledge of USFDA regulations and guidelines. Well-read with 510(k), PMA and STED practice.

Soft Skills: Attention to detail, Ability to learn quickly and adapt to a fast-paced dynamic culture, Independent decision-making, Time-management, Communication with clients, Strong interpersonal skills, critical thinking, Team builder, Responsible.

Experience

Lazhora Medical Cosmetics Chennai, India

Regulatory Affairs Intern Jan 2014- Feb. 2015

Perform regular office functions in congruence with specific projects as needed

Participate in regulatory functions related to product registration, importation, sale and promotion of cosmetics and other consumer products

Assist in the preparation of technical information such as; Certificate of Analysis, Specifications, Certificate of Ingredient, Standard Operating Procedure

Assist in the research of laws and regulations pertaining to government approval processes, product labeling requirements, ingredient/formula acceptability, promotional compliance and other regulatory related area as necessary

Help prepare correspondence to inquiries from various government agencies

Assist in the evaluation of ingredient/formula, product label and advertisement materials for market compliance

Organize and maintain market folders

Perform other Regulatory Affairs functions as assigned

Anna University Chennai, India

Student Researcher Dec 2013- May 2014

Bachelor’s Dissertation Title: Study On Bacterial Efflux Pumps And Their Interactions With Antibiotics.

Cadila Pharmaceuticals Ltd. Ahmedabad, India

Clinical Trial Documentation Intern Jun 2013- Aug 2013

Interned in a drug manufacturing company that obeys USFDA regulations.

Assisted with the clinical trial tasks in a Phase 1 comparative study trial.

Work with clinical staff and physicians to obtain information for patient records.

Ensure that all patient documents and records are maintained in accordance with legal guidelines.

Review accuracy, quality and completeness of clinical records.

Facilitated in documentation of clinical details of patients' conditions, diagnoses, and progress

Ensured all relevant information pertaining of patient care is documented into the Trial Master File and reviewed for quality.

Provided assistance with Electronic Document Publishing support (i.e., scanning, OCR, rendering, bookmarking/linking, document verification and compiling)

Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival.

Orchid Chemicals and Pharmaceuticals Ltd. Chennai, India

Research and Development Intern Nov. 2011 Jan. 2012

Gained hands-on experience in animal handling and performed quantitative tests to determine the dose, toxic dose, dose response relationship, comparative efficacy and pharmacologic action of an actual drug.

Checked the kinetic profile of the drug and methodology for selecting the route of administration in humans

Additional Experience

Make a Difference Chennai, India

English Teaching Volunteer 2012-2013

Taught Oxford English Syllabus to underprivileged kids in shelter homes.

Discover Intern 2013-2014

Taught Science and Mathematics based simple experiments to elementary school students.

Scholarship: Secured a scholarship by the central government of India in the Central Sector Scholarship

Leadership Activities:

College council: Class Representative (2011-2012); Placement Representative, Centre for Biotechnology (2013-2014)

Head of the Green Committee of Biotechcellence (National Technical Symposium of Association of Biotechnologist’s), Centre for Biotechnology

Member of Youth Red Cross, honored as Best Social Worker (2013)

Event Organizer for Kalakrithi (National level cultural festival conducted by the students of Anna University).

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