A Regulatory Affairs Intern provides support to the regulatory department and ensures maintenance and organization of regulatory files for proper tracking of information and archiving of regulated documents. Key internship duties often listed on the Regulatory Affairs Intern Resume are – auditing and updating regulatory correspondence files/logs and submission archives; shadowing RA personnel to learn drug development process in a real-world environment, and participating in dossier preparation and submission.
To ensure success and to progress in this career, the following skills are expected from job applicants – interest in FDA regulated environment as applicable to drug development for clinical trials, interest in vaccines, or biologics; interest in electronic database management and structured information storage, good written and verbal communication skills, strong attention to details. A current bachelor’s science or master’s degree in RA or equivalent formal training is needed.
Headline : Product Development Regulatory (PDR) intern focusing on cancer immunotherapy drug development, looking for full-time employment. Performing foundational work to enable Medpace to better leverage regulatory precedent when advising clients on regulatory strategies, Collaborating with the Medpace informatics team to expand our use of data analytics within regulatory affairs.
Skills : Microsoft Word, Registration Strategist, Study Assistant.
Description :
Facilitated and participated in clinical filing team meetings, write minutes, prepare US eCTD Module 1 documents, support preparation for the pre-sBLA meeting, support the UPSI updating process.
Supported the regulatory process to help enable initiation of a Phase 3 study in Prostate cancer.
Supported a pre-IND/Phase 3 teleconference with the FDA including setting agenda and drafting needed team documents and executive summary.
Led documentation preparation for application of an administrative split IND and supported the response to IND comments from the FDA.
Supported coordination of responses to FDA, CHMP and VHP information requests to enable timely submission of responses.
Exposured to US and EU registration strategies; provide regulatory positions on study country selection; review and support FDA, CHMP Scientific Advice, VHP and CTA submissions.
Study maintenance Represented both US and EU regulatory functional at fast paced cross-functional global study teams for 13 separate studies from phase I to IV under 4 different INDs.
Experience
5-7 Years
Level
Executive
Education
GED
Regulatory Affairs Intern Resume
Objective : Regulatory Affairs Intern with 10 years of scientific research and regulatory affairs experience as well as ability to support a complex matrix organizational environment. Scientific experience includes determining mechanism of action, developing assays, preparation of scientific manuscripts and presentations at National meetings.
Skills : Regulatory Affairs, Scientific Research.
Description :
Reviewed and prepared an IND CMC Information Amendment for a biologic product.
Documented IND annual report.
Managed cross-functional review and approval of response to Complete Response letter from FDA.
Supported the International Regulatory Group in preparation of Core Dossier - CMC section for a NME to enable the filing of Marketing Authorization Application (MAA).
Prepared and submitted Certificate of Pharmaceutical Product (CPP) applications.
Researched regulatory guidelines, and prepared Table of Contents for New Drug Submission (NDS) as well as Clinical Assessment Package to Health Canada for an orphan NME approved in the EU.
Reviewed pre-submission meeting request for priority review of an orphan NME NDS to Health Canada.
Experience
2-5 Years
Level
Executive
Education
MS
Regulatory Affairs Intern Resume
Headline : A goal-oriented, self-motivated graduate looking to work in Regulatory Affairs or Quality Assurance, Preparing and supporting submissions and change orders, including gathering technical documentation and drafting submissions to support the registration of medical devices.
Read and correlated FDA, ICH and CDSCO (India) guidance documents.
Understood the application of USP monographs in regulatory submissions.
Reviewed IND, NDA and ANDA submissions for the United States.
Reviewed labelling section for ANDA submissions.
Independently compiled a prototype eCTD submission as per FDA requirements giving details of the contents of each section for both NDAs and ANDAs separately.
Assessed CMC documentation and identified loopholes in the data.
Suggested potential amendments to various sections of NDAs and ANDAs.
Experience
5-7 Years
Level
Executive
Education
M.S. In Pharmaceutical Sciences
Regulatory Affairs Intern Resume
Objective : To obtain a position in Regulatory Affairs, where I can use my educational and linguistic background to benefit the company, as well as for my personal growth in the field, as a Regulatory Affairs Specialist.& Maintaining regulatory affairs files, Developing working relationships with key personnel at the business unit and representatives of international business centers / manufacturing sites.
Communicated with marketing and sales teams to address the local policies Accomplishments.
Greatly improved the document quality.
Successfully solved product packaging problems for marketing purposes.
Took initiative to learn about QbD in order to prepare for FDA's full implementation of QbD for ANDAs by through team training sessions.
Experience
2-5 Years
Level
Executive
Education
MS In Pharmaceutical Science
Regulatory Affairs Intern Resume
Objective : Highly qualified Regulatory Affairs Intern with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Understands and follows company procedures and regulatory requirements, May preparing and presenting oral and written project updates and technical discussions, Participating in special projects, as required.
Skills : Microsoft Word, Microsoft PowerPoint, Microsoft Excel,SPSS, ANOVA,UV Spectrophotometer, TLC, HPLC, HPTLC, T-Tests,.
Description :
Prepared and reviewed Product Dossiers for regulatory compliance in eCTD structure.
Coordinated with Quality Assurance, Quality Control, Formulation & Development departments and reviewing technical documents such as Process Validation, Analytical Method Validation, Stability data, Stability Chromatograms.
API, Finished Product and Raw Material specifications.
Submitted and handled of varied applications, renewals, withdrawal applications, etc.
Knowledged of Regulatory Guidelines of USFDA, EMEA, TGA, etc.
Prepared note to file [no-510(k)] rationales for product updates.
Wrote notice of change documents to be submitted to international geographies detailing changes made to product lines.
Experience
2-5 Years
Level
Executive
Education
MBA In Healthcare Management
Regulatory Affairs Intern Resume
Objective : A vision-oriented, global-minded professional with a high-level of professionalism and a teachable attitude. A self-starter, highly adaptable in changing and fast-paced environments. Effective oral and written communicator with the ability to work successfully in multi- cultural settings.
Composed dossiers for Latin American customs authority.
Researched Saudi Arabian import laws of fertilizers.
Ability to prioritize and manage multiple projects while meeting important deadlines.
Ability to work successfully on a team and to work independently on special assignments.
Improved written and oral communication skills, especially with high-level and management employees.
Expedited launch of a Standard Operating Procedures (SOP) project for a pharmaceutical company by developing strategies for researching, drafting, analyzing, and editing new SOPs via teamwork and met a timely deadline.
Audited Good Laboratory Practices (GLP) laboratory documentation in preparation for Investigational New Drug (IND) submission.
Experience
2-5 Years
Level
Executive
Education
GED
Regulatory Affairs Intern Resume
Objective : To obtain a Regulatory Affairs Intern position within the accounting or finance fields, Ability to plan and schedule multiple priorities in a concurrent fashion, reviewing, collating, and summarizing scientific and technical data, handling master documents, drawings, and specifications with a high degree of confidentiality.
Skills : R Programming, Excel, LaTeX, Labview, AgenaRisk, FDA, GDP.
Description :
Created FDA Communication Databases, following GDP guidelines, documenting several years of company interactions pertaining to 510(k)s, DMF, PIND, IND, and NDAs, thereby: Improving Proteus/FDA Response time Having about 150+ files in one, easy-to-access location Adding search capabilities to FDA interactions Increasing efficiency to FDA responses Presented a poster with data analytics on response-time and Proteus/FDA Communications to Chief Medical Officer, Regulatory Dept.
Assisted in preparing the GUDID submission and attended weekly cross-functional UDI meetings.
Researched and summarized competitor medical devices to enhance regulatory strategy and observe current industry practice.
Studied about the Software Life Cycle, Root Cause Analysis, CE marking, Briefing Book and PIND activities.
Attended FDA's live Webinars on Risk Management for Biocompatibility Evaluation, Submitting REMs in SPL format and Deciding when to submit a 510(k) for a change/software change in existing Device and Software.
Performed data analysis and clean up on large data sets.
Assisted department in becoming compliant with FDA regulated electronic medical device reports.
Experience
0-2 Years
Level
Entry Level
Education
Master Of Science
Regulatory Affairs Intern Resume
Summary : Regulatory Affairs Intern with 3 years of experience in Developing and maintaining regulatory files and documents, Assisting in preparation documents for submission, Ensuring documentation meets FDA and ISO regulations, Assisting in the work of identifying, addressing, and eliminating causes of non-compliance, Involvement in preparing Standard Operating Procedures.
Skills : MS Office, Master Control, DocuShare, MFG Pro, AdvancedMD, PeopleSoft Experienced - SQL, QuickBooks, Brainware, IAN, Adobe Suite - Dreamweaver, PhotoShop, And Flash Fluent In Spanish.
Description :
Performed work process analysis to allow for process consolidation.
Audited Good Clinical Practices (GCP) clinical trial documentation to confirm FDA compliance.
Assisted in the compilation of CE Technical Files for new product releases in Europe.
Supported the program director in researching scientific advice meeting request guidelines as well as planning meetings with European national agencies such as Afssaps, BfRaM and Paul-Ehrlich-Institut (PEI) for an orphan biologic product in phase 1 clinical trial.
Trained study management teams on regulatory requirements and provide regulatory guidance.
Reviewed clinical study protocols and other clinical trial documentation, ensuring accuracy and compliance with current regulations.
Maintained and updated regulatory strategic documentation on a complex program that includes several INDs, different indications and several stakeholders.
Experience
7-10 Years
Level
Management
Education
Masters In Business Administration
Regulatory Affairs Intern Resume
Objective : Regulatory Affairs Intern professional with 2 years of experience in Life Sciences industry. Strong understanding of Clincal Research, Regulations of Drugs and Medical devices. Experienced in managing the Regulatory documents, facing Inspections by appropriate Regulatory authorities, analyzing the complaints and reporting accordingly.
Skills : Polymer/Peptide Synthesis, Drafting.
Description :
Provided overall operational and administrative support for the DC office which may include supervision of office vendors, supply management, arranging meeting agendas and ensuring necessary supplies and required materials are managed.
Supported the Strategy Team – with an emphasis on Congressional and Executive Branch activities.
Provided open-source research, analysis, and draft briefing papers.
Tracked key congressional hearings and stakeholder/think tank engagements.
Summarized government and congressional atmospherics to help align Meta’s products and services with defense demands.
Supported market engagement efforts where required where customer knowledge or intimacy may help Meta mitigate any known risk and progress its prospects.
Drafted summaries and analyses of market atmospherics.
Experience
2-5 Years
Level
Executive
Education
Master Of Science
Regulatory Affairs Intern Resume
Objective : Motivated contributor, delivery-focused, strong work ethic, proven team member, good verbal and written communication skills, Preparing agendas, attending and transcribing minutes for meetings, maintains calendars, schedules appointments and meeting makers, conference rooms, etc, Distributing mail, copies materials, collects and collates information and distributes documents as requested, Coordinating the works of the office with the work of other Nursing areas in the Nursing Department and for recognizing the need for such coordination in various circumstances.
Skills : Microsoft Office, Time Management, Teamwork, Detail Oriented, Data Analysis, Data Collection, Project Management, Documentation, Master Control.
Description :
Effectively collaborated with department and cross-functional team members and comfortable working independently with limited direction/supervision
Solved practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Read and interpreted documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Wrote routine reports and correspondence.
Participated actively in the management of the Nursing Service performing a wide range of administrative, analytical and budgeting functions.
Performed wide range of of responsibility, including; but not limited to budget, personnel, travel, correspondents, timekeeping, supplies and equipment.
Maintained an accurate record of tasks and action items, tracks completion, and follows up with responsible parties to fulfill requests.
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