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.
Objective : Passionate Regulatory Affairs Intern with 2 years of hands-on experience in clinical trial support and regulatory documentation. Skilled in preparing eCTD submissions and coordinating with cross-functional teams to ensure compliance with FDA and EU regulations. Eager to leverage my background in life sciences to contribute effectively to regulatory strategies and enhance operational efficiency.
Facilitated clinical filing meetings, documenting minutes and preparing US eCTD Module 1 documents to support regulatory submissions.
Contributed to the regulatory process for a Phase 3 study in prostate cancer, ensuring compliance with regulatory standards.
Coordinated a pre-IND teleconference with the FDA, preparing agendas and drafting necessary documents.
Led the preparation of documentation for an administrative split IND, addressing FDA comments effectively.
Managed responses to FDA and CHMP information requests, ensuring timely and accurate submissions.
Gained exposure to US and EU registration strategies, providing insights on study country selection and regulatory submissions.
Represented regulatory functions for 13 studies from Phase I to IV across multiple INDs, ensuring alignment with regulatory requirements.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Regulatory Intern Resume
Objective : Dedicated Regulatory Intern with 2 years of experience in regulatory compliance and documentation management. Proficient in preparing submissions for FDA and Health Canada, while ensuring adherence to global regulatory standards. Committed to leveraging analytical skills and a background in life sciences to support effective regulatory strategies and enhance compliance processes.
Skills : Regulatory Compliance, Research Skills, Attention To Detail, Problem Solving, Team Collaboration
Description :
Assisted in preparing regulatory submissions for product approvals and compliance.
Conducted research on regulatory requirements for various markets.
Coordinated cross-functional reviews and approvals of responses to FDA Complete Response letters.
Reviewed and analyzed product labeling for compliance with regulations.
Supported the development of regulatory strategies for new products.
Researched regulatory guidelines and crafted a Table of Contents for New Drug Submissions (NDS) and Clinical Assessment Packages for Health Canada.
Collaborated with cross-functional teams to ensure regulatory compliance.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Regulatory Affairs Intern Resume
Objective : Enthusiastic Regulatory Affairs Intern with 2 years of robust experience in regulatory compliance and submission processes. Adept at navigating FDA and EU regulatory frameworks, preparing eCTD submissions, and collaborating with diverse teams to ensure adherence to guidelines. Passionate about leveraging my scientific knowledge to support the development and implementation of effective regulatory strategies.
Interpreted FDA, ICH, and CDSCO guidance documents to ensure compliance in regulatory submissions.
Applied USP monographs in the preparation of regulatory documentation.
Reviewed IND, NDA, and ANDA submissions for accuracy and compliance with regulatory standards.
Assessed labeling sections for ANDA submissions to ensure clarity and adherence to regulations.
Independently created a prototype eCTD submission aligned with FDA requirements, detailing content for NDAs and ANDAs.
Evaluated CMC documentation, identifying gaps and suggesting amendments for regulatory compliance.
Provided recommendations for enhancing various sections of NDAs and ANDAs based on regulatory feedback.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Regulatory Affairs Trainee Resume
Objective : Driven regulatory professional with 5 years of experience in compliance, documentation, and regulatory submissions. Proficient in managing eCTD submissions and ensuring adherence to FDA and EU regulations. Eager to leverage a solid foundation in life sciences to enhance regulatory strategies and operational processes.
Managed regulatory documents and ensured compliance with internal and external standards.
Translated and reviewed internal product reports for regulatory accuracy.
Supported and drafted product applications, ensuring adherence to regulatory guidelines.
Collaborated with marketing and sales teams to align product strategies with local regulations.
Enhanced document quality through rigorous review processes, leading to improved submission outcomes.
Initiated training on Quality by Design (QbD) principles in preparation for FDA implementation.
Monitored regulatory changes to keep the team informed and compliant.
Experience
2-5 Years
Level
Executive
Education
B.S.
Regulatory Affairs Intern Resume
Objective : Aspiring Regulatory Affairs Intern with 2 years of experience in regulatory compliance and submission processes. Proficient in eCTD preparation and adept at collaborating with cross-functional teams to ensure adherence to FDA and global regulations. Ready to apply my life sciences knowledge to support regulatory strategies and enhance compliance efforts.
Maintained regulatory documentation and tracking systems.
Collaborated with Quality Assurance and Quality Control teams to review technical documents including Process and Analytical Method Validation.
Participated in meetings to discuss regulatory updates and strategies.
Managed submissions and handled various applications, including renewals and withdrawals.
Maintained up-to-date knowledge of Regulatory Guidelines from USFDA, EMEA, and TGA.
Drafted notes to file 510(k) rationales for product modifications.
Created notice of change documents detailing updates to product lines for international submissions.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Regulatory Affairs Associate Intern Resume
Headline : Regulatory Affairs professional with 7 years of extensive experience in compliance, submission management, and regulatory documentation. Demonstrated expertise in navigating FDA and global regulations, enhancing submission processes, and collaborating with cross-functional teams. Committed to leveraging my analytical skills and scientific knowledge to drive effective regulatory strategies and support product development.
Composed regulatory dossiers for compliance with Latin American customs authorities, enhancing submission accuracy.
Researched import laws for Saudi Arabia, ensuring adherence to local regulations for fertilizer products.
Prioritized and managed multiple regulatory projects, consistently meeting critical deadlines.
Collaborated successfully within cross-functional teams to execute special assignments.
Enhanced communication skills through interactions with high-level management and diverse teams.
Led the development of strategies for the timely launch of SOP projects, resulting in improved compliance.
Conducted audits of Good Laboratory Practices (GLP) documentation in preparation for Investigational New Drug (IND) submissions.
Experience
5-7 Years
Level
Executive
Education
M.S. in RA
Regulatory Affairs Intern Resume
Objective : Detail-oriented Regulatory Affairs Intern with a strong foundation in compliance and regulatory processes. Skilled in researching and analyzing regulatory requirements for pharmaceuticals and medical devices. Eager to support cross-functional teams in ensuring product compliance and facilitating submissions to regulatory agencies. Committed to maintaining high standards of quality and safety in the healthcare industry.
Skills : Market Research, Data Analysis And Reporting, Technical Documentation, Regulatory Compliance Software, Risk Assessment Techniques, Data Interpretation
Description :
Created and maintained FDA communication databases, improving response times by consolidating 150 files into a searchable format.
Assisted in the preparation of GUDID submissions and actively participated in weekly cross-functional UDI meetings.
Conducted competitive analysis of medical devices to refine regulatory strategy and align with industry trends.
Studied regulatory frameworks including Software Life Cycle, CE marking, and PIND activities to enhance compliance knowledge.
Attended FDA webinars on risk management and submission processes to stay updated on regulatory changes.
Performed data analysis and cleanup on large datasets to support regulatory submissions.
Supported the regulatory team in ensuring compliance with FDA regulations for electronic medical device reports.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Regulatory Affairs Summer Intern Resume
Objective : Regulatory Affairs professional with 5 years of diverse experience in compliance, documentation, and submission processes. Adept at preparing eCTD submissions and ensuring adherence to FDA and international standards. Committed to leveraging a robust background in life sciences to support innovative regulatory strategies and enhance operational excellence.
Skills : Regulatory Documentation Management, Presentation Skills, Document Control Systems, Manufacturing Compliance Tools, Clinical Data Management, Ethics In Research
Description :
Conducted comprehensive audits of clinical trial documentation to ensure FDA compliance.
Collaborated on the preparation of CE Technical Files for product launches in Europe.
Supported the program director in liaising with European regulatory agencies for orphan biologic products.
Provided regulatory guidance to study management teams, enhancing compliance understanding.
Reviewed clinical study protocols for accuracy and regulatory adherence.
Maintained regulatory strategic documentation for multiple INDs and stakeholders.
Streamlined the submission process, improving efficiency and compliance tracking.
Experience
2-5 Years
Level
Executive
Education
B.S. Biomed.
Regulatory Affairs Intern Resume
Objective : Regulatory Affairs Intern with 2 years of experience in regulatory documentation and compliance in the life sciences sector. Proficient in preparing eCTD submissions and conducting thorough analyses of regulatory requirements. Committed to supporting teams in achieving compliance with FDA and EU standards while enhancing operational efficiency through strategic contributions.
Skills : Document Management, Data Management, Process Improvement, Regulatory Intelligence, Risk Assessment, Standard Operating Procedures
Description :
Provided operational support for regulatory compliance, ensuring adherence to documentation standards.
Assisted in the preparation of meeting agendas and materials for regulatory discussions.
Conducted analysis of regulatory frameworks to inform strategic decision-making.
Supported the development of internal processes to streamline regulatory submissions.
Managed and organized regulatory documentation to facilitate timely submissions.
Collaborated with teams to ensure alignment with FDA and EU regulations.
Tracked and reported on compliance metrics to identify areas for improvement.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Regulatory Affairs Intern Resume
Objective : Motivated Regulatory Affairs Intern with a background in life sciences and a passion for regulatory compliance. Experienced in assisting with the preparation of regulatory submissions and documentation. Proficient in conducting literature reviews and analyzing regulatory guidelines. Aiming to contribute to the successful launch of products while ensuring adherence to industry regulations and standards.
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