Working in the Research labs, a Regulatory Assistant ensures that every clinical study follows regulations. The job duties commonly listed on the Regulatory Assistant Resume include – keeping up to date with regulations, ensuring that everyone in the lab follows correct procedures, assisting in obtaining and maintaining government approval for drugs, medical devices, and related materials; working on document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Other core duties include maintaining communication between all departments and ensuring a smooth workflow.
Regulatory assistants must be able to work in a demanding environment and be able to adhere to protocols. They have to stay up to date on their area of expertise and possess strong communication, project management, and analytical skills as well. Attention to detail and the ability to adapt quickly to changing regulations are also needed. Every professional in this field is expected to possess at least a bachelor’s degree in subjects such as chemistry, medicine, engineering, biological science, or pharmacy.
Objective : Dedicated professional with two years of experience in regulatory compliance, adept at ensuring adherence to governmental standards. Proven ability to manage documentation, communicate effectively with stakeholders, and support regulatory submissions. Eager to contribute strong organizational skills and compliance knowledge to enhance operational efficiency in a dynamic environment.
Skills : Regulatory Documentation Management, Data Analysis And Reporting, Project Coordination, Document Management
Description :
Managed the preparation and submission of regulatory documents, ensuring accuracy and compliance with guidelines.
Coordinated the filing of IND safety reports and maintained comprehensive regulatory binders.
Transcribed and organized safety reports for timely submission to regulatory agencies.
Monitored adverse effects of study drugs and maintained detailed spreadsheets for analysis.
Executed all tasks in accordance with Good Clinical Practice (GCP) standards.
Ensured the timely submission of complete and accurate documents to regulatory authorities.
Collaborated with cross-functional teams to align regulatory strategies with organizational goals.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Reg. Affairs
Junior Regulatory Assistant Resume
Objective : With five years of experience in regulatory compliance, I excel in managing documentation and ensuring adherence to industry regulations. My strong organizational and communication skills facilitate effective collaboration with stakeholders and regulatory agencies. Committed to enhancing compliance processes, I aim to contribute to operational efficiency in a dynamic regulatory environment.
Skills : Record Keeping, Process Improvement, Stakeholder Engagement, Legal Research, Audit Preparation
Description :
Provided comprehensive administrative support to regulatory specialists, enhancing departmental efficiency through improved processes and policies.
Managed an average of 100,000 monthly regulatory permit transactions, ensuring timely and accurate processing.
Gathered and verified regulatory data agreements, permits, and correspondence from relevant business units.
Conducted thorough research and verification of authorizations for expenditures to ensure compliance with regulatory requirements.
Coordinated rig moves by facilitating communication with internal departments and government entities, ensuring compliance with regulations.
Documented rig changes in accordance with guidelines from agencies such as the Coast Guard and BSEE.
Utilized e-File system to maintain and organize departmental regulatory records efficiently.
Experience
2-5 Years
Level
Junior
Education
B.S. Reg. Affairs
Regulatory Assistant Resume
Headline : Results-oriented Regulatory Assistant with 7 years of experience in compliance and documentation management. Proven expertise in preparing regulatory submissions and collaborating with stakeholders to ensure adherence to industry standards. Driven to enhance operational processes through meticulous organization and attention to detail, I am committed to supporting regulatory initiatives that advance organizational goals.
Supported Regulatory Associates in preparing and reviewing regulatory documentation, ensuring accuracy and compliance.
Organized and maintained electronic filing systems for regulatory submissions and audit documents.
Managed audit-related paperwork, coordinating with internal and external stakeholders to ensure timely submissions.
Collected and verified documentation for audits from the DEA, FDA, and Board of Pharmacy, ensuring thorough compliance.
Oversaw daily C2 submissions and data collection, maintaining error-free records and statistics.
Logged client information accurately into C2 systems, enhancing data integrity.
Compiled comprehensive client files to track progress and regulatory compliance.
Experience
5-7 Years
Level
Senior
Education
B.S. in Reg. Affairs
Regulatory Compliance Assistant Resume
Objective : A results-focused Regulatory Compliance Assistant with 5 years of experience in ensuring regulatory adherence and optimizing compliance processes. Skilled in documentation management, stakeholder communication, and regulatory submissions, I am dedicated to enhancing operational efficiency. My proactive approach and attention to detail contribute significantly to maintaining high compliance standards within dynamic environments.
Skills : Compliance Management Software, Attention To Detail, Regulatory Frameworks, Database Management, Risk Assessment, Policy Development
Description :
Tested and documented processes for the transition to the Optiva computer system, ensuring compliance with industry standards.
Conducted training sessions for cross-departmental staff on regulatory compliance and software usage.
Reviewed and maintained production batch records for annual regulatory audits.
Updated master files for FDA inspections, including creating accurate Material Safety Data Sheets (MSDS).
Managed customer communications regarding compliance issues and facilitated production sample approvals.
Input formulas into Optiva to streamline pricing and production workflows.
Tracked testing requirements for products, organizing samples and maintaining comprehensive test records.
Experience
2-5 Years
Level
Executive
Education
B.S. in Reg. Affairs
Regulatory Assistant Resume
Summary : Accomplished Regulatory Assistant with a decade of experience in compliance management and regulatory documentation. Expertise in liaising with stakeholders and ensuring compliance with industry standards. Proven ability to streamline processes and enhance operational efficiency, dedicated to supporting regulatory initiatives that drive organizational success.
Served as the primary liaison between regulatory bodies and internal teams, ensuring clear communication and compliance.
Managed and organized regulatory documentation, facilitating smooth submission processes.
Conducted regular audits of compliance practices, identifying areas for improvement.
Coordinated training sessions to educate staff on regulatory updates and compliance requirements.
Prepared comprehensive reports for management on compliance status and regulatory changes.
Collaborated with cross-functional teams to develop and implement effective compliance strategies.
Monitored changes in regulations to ensure ongoing compliance across all departments.
Experience
7-10 Years
Level
Management
Education
B.S. Reg. Affairs
Regulatory Affairs Assistant Resume
Objective : Enthusiastic Regulatory Affairs professional with two years of experience in compliance and documentation management. Skilled in preparing regulatory submissions and ensuring adherence to industry standards. I am committed to fostering effective communication with stakeholders and enhancing operational processes to support regulatory initiatives.
Skills : Communication Skills, Regulatory Compliance Analysis, Problem Solving, Team Collaboration
Description :
Coordinated the preparation and submission of regulatory documents for Oncology studies, ensuring compliance with federal regulations.
Managed weekly reporting for the Children’s Oncology Group, enhancing communication among team members.
Facilitated collaboration with various professionals regarding critical issues affecting Oncology studies.
Conducted assessments of compliance standards and implemented corrective actions as needed.
Provided comprehensive support in the development of regulatory strategies for clinical trials.
Assisted in the preparation of audit materials, ensuring readiness for inspections.
Maintained accurate records and documentation to support regulatory compliance efforts.
Experience
0-2 Years
Level
Fresher
Education
B.S. Biology
Regulatory Assistant Resume
Summary : Accomplished Regulatory Assistant with 10 years of experience in compliance and regulatory documentation. Skilled in managing submissions and collaborating with cross-functional teams to ensure adherence to regulations. My meticulous approach enhances operational efficiency and supports organizational goals, making me a valuable asset in dynamic regulatory environments.
Skills : Cross-functional Collaboration, Regulatory Reporting, Information Gathering, Analytical Thinking, Client Interaction, Cross-functional Support
Description :
Conducted comprehensive research on regulatory submissions, product requirements, and competitive analysis to support compliance efforts.
Assisted in achieving product registrations and business objectives through effective project management.
Monitored product incidents and reported findings to regulatory agencies, ensuring timely compliance.
Coordinated with product managers to align on regulatory requirements and documentation.
Developed and maintained an internal tracking system for confidential Statement of Formulas, enhancing data integrity.
Completed Personal Protective Equipment Training Certification through workshops organized by the US Environmental Protection Agency.
Managed vendor applications and ensured compliance with regulatory standards.
Experience
10+ Years
Level
Executive
Education
B.S. in RA
Regulatory Support Assistant Resume
Objective : Seasoned Regulatory Support Assistant with five years of experience in compliance and documentation management. I specialize in ensuring regulatory adherence and streamlining submission processes. My strong analytical skills and attention to detail enhance collaboration with stakeholders and regulatory bodies, driving operational excellence in fast-paced environments.
Skills : Documentation Management, Research Skills, Time Tracking, Software Proficiency, Regulatory Updates, Issue Resolution
Description :
Reviewed permit applications for accuracy and completeness related to U.S. Water Sheds.
Assisted in preparing regulatory submissions for product approvals and compliance.
Prepared application packets and correspondence for signatures to ensure timely submissions.
Provided exceptional customer service to applicants and handled inquiries from the public.
Conducted database and file research to align historical permit actions with new applications.
Performed quality audits of essential documents, ensuring compliance with regulatory standards.
Led audits of electronic Tile Master Files (eTMF), identifying errors per FDA regulations.
Experience
2-5 Years
Level
Consultant
Education
B.S. Reg. Affairs
Regulatory Assistant Resume
Headline : Proficient Regulatory Assistant with 7 years of experience in compliance and documentation management. Skilled in preparing and submitting regulatory filings while ensuring strict adherence to industry standards. My expertise in stakeholder communication and problem resolution fosters operational excellence and promotes effective collaboration. I am dedicated to advancing regulatory initiatives that align with organizational objectives.
Skills : Regulatory Auditing, Compliance Risk Assessment, Regulatory Compliance In Clinical Trials, Meeting Coordination, Technical Documentation, Data Entry Accuracy
Description :
Supported audits and inspections by preparing necessary documentation.
Compiled, reviewed, and published regulatory submissions while maintaining accuracy and attention to detail.
Managed the IND maintenance process, ensuring timely updates and compliance with regulatory changes.
Maintained a comprehensive database for regulatory packages and informed consents, enhancing data accessibility.
Reviewed regulatory packages for clinical studies, ensuring adherence to protocols and standards.
Tracked submission timelines and ensured deadlines were met.
Resolved regulatory issues from internal and external stakeholders, facilitating effective communication with governmental agencies.
Experience
5-7 Years
Level
Senior
Education
B.S. Regulatory Affairs
Regulatory Assistant Resume
Objective : Detail-oriented Regulatory Assistant with over 3 years of experience in supporting compliance and regulatory processes. Proficient in preparing documentation, conducting research, and maintaining regulatory databases. Strong communication skills and a solid understanding of industry regulations ensure effective collaboration with cross-functional teams to meet compliance deadlines.
Skills : Report Writing, Technical Writing, Training Coordination, Data Entry, Strategic Planning
Description :
Oversaw inventory management for departmental supplies, ensuring timely orders and receipt verification.
Facilitated IRB approval processes for study documentation, ensuring compliance with regulatory standards.
Utilized software applications to improve workflow efficiency and study activities.
Assisted with regulatory logistics, managing paperwork for customer orders and import/export permits.
Created and maintained customer files for easy retrieval and organization.
Updated market data and flagged suspicious orders, documenting investigations as necessary.
Processed renewal applications for state licensing to maintain compliance.
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