A Regulatory Coordinator is responsible for coordinating all regulatory concepts of the company. Typical work activities seen on the Regulatory Coordinator Resume include – reviewing all protocols and implementing improvements continually; resolving problems relating to non-compliance; working with team members to adhere to guidelines; preparing and filing reports, documents, permits, and presentations; guaranteeing compliance with government regulations through research, assessment and gathering data; and reviewing compliance with regulations testing trials.
Apart from formal education, the coordinators will need the following professional skills to carry out their work effectively and productively – strong observation skills, the ability to keep track of multiple streams of information, sound moral values; staying aware of the code of ethics related to the industry working for; and computer proficiency. A business law or paralegal studies is commonly seen on most resumes.
Objective : Dynamic Regulatory Coordinator with two years of experience in managing regulatory submissions and compliance in clinical research settings. Proven ability to collaborate with cross-functional teams, ensuring adherence to regulatory standards and timelines. Eager to leverage analytical skills and regulatory knowledge to support innovative clinical trials and enhance operational efficiency.
Promoted from Research Coordinator Assistant to Regulatory Coordinator, managing regulatory compliance for over 60 research studies daily.
Collaborated with Study Coordinators and physicians to gather necessary information for regulatory document submissions.
Created and maintained comprehensive master regulatory files from pre-study site visits to study close-out.
Coordinated the preparation of regulatory documents for sponsors, ensuring thorough and timely submissions.
Coordinate regulatory submissions and ensure compliance with local and international regulations.
Engaged with the Clinical Research Director to discuss new studies and provide updates on ongoing trials.
Scheduled and coordinated monitor visits, ensuring compliance with regulatory standards and updating IRB summaries as necessary.
Experience
0-2 Years
Level
Entry Level
Education
M.S. Clinical Research
Senior Regulatory Coordinator Resume
Summary : Accomplished Senior Regulatory Coordinator with over 10 years of expertise in overseeing regulatory submissions and compliance for clinical trials. Adept at fostering collaboration across multidisciplinary teams to ensure adherence to regulatory standards. Committed to enhancing clinical research processes and operational efficiency through strategic oversight and meticulous documentation.
Skills : Regulatory Submission Management, Problem Solving, Stakeholder Engagement, Training Development, Report Generation
Description :
Oversaw all regulatory affairs operations for diverse clinical trials, ensuring compliance with local and federal regulations.
Managed the timely completion of submissions and annual reviews for clinical trial protocols under Institutional Biosafety Committee (IBC) guidelines.
Coordinated the implementation of clinical trials and pharmaceutical protocols in strict accordance with regulatory standards.
Trained and mentored new personnel on regulatory processes and clinical research protocols.
Maintained organized regulatory documentation for clinical research protocols, ensuring accuracy and compliance.
Conducted audits of clinical research records, rectifying discrepancies per quality control policies.
Submitted regulatory documents to the DAIDS Protocol Registration System and ensured follow-up compliance.
Experience
7-10 Years
Level
Senior
Education
M.S. Clinical Research
Regulatory Coordinator Resume
Headline : Accomplished Regulatory Coordinator with 7 years of extensive experience in managing regulatory submissions and compliance within clinical research. Proficient in developing and executing regulatory strategies while ensuring adherence to global standards. Adept at fostering collaboration among diverse teams and committed to enhancing the efficiency and success of clinical trials.
Assist in the development of regulatory strategies for new products.
Tracked global regulatory strategies and ensured projects were completed within established timelines.
Provided regulatory guidance to team members, enhancing the development of effective regulatory strategies.
Facilitated timely communication on project-specific regulatory issues among cross-functional teams.
Represented the Regulatory Project Director at key team meetings, including Safety and Global Project Teams.
Supported trial continuation activities, ensuring adherence to regulatory requirements.
Ensured all global submissions were of the highest quality, expediting acceptance by regulatory authorities.
Experience
5-7 Years
Level
Senior
Education
M.Sc.
Junior Regulatory Coordinator Resume
Objective : Regulatory professional with 5 years of experience in clinical trial compliance and regulatory submissions. Skilled at collaborating with diverse teams to ensure adherence to regulatory standards and streamline processes. Passionate about leveraging analytical expertise to enhance operational efficiency and support innovative clinical research initiatives.
Skills : Process Improvement, Project Management, Change Management, Audit Coordination, Technical Writing, Communication Skills
Description :
Created and maintained regulatory submissions, ensuring compliance with FDA and ICH guidelines.
Collaborated with cross-functional teams to prepare and update submission documents for clinical trials.
Reviewed and audited labeling for accuracy and compliance with regulatory standards.
Ensured timely submission of necessary documents for new product launches.
Participated in cross-departmental meetings to streamline regulatory processes and enhance collaboration.
Assisted in the management of Trial Master Files (TMF) for clinical studies.
Conducted training sessions on regulatory requirements for team members.
Experience
2-5 Years
Level
Junior
Education
B.S. Biology
Regulatory Coordinator Resume
Objective : Detail-oriented Regulatory Coordinator with over 5 years of experience in managing compliance and regulatory submissions. Proven track record in preparing and reviewing documentation for FDA and other regulatory bodies. Strong analytical skills and ability to interpret complex regulations, ensuring adherence to industry standards. Excellent communication and project management skills, fostering collaboration across cross-functional teams.
Skills : Industry Knowledge, Interpersonal Skills, Project Coordination, Record Keeping, Cross-functional Teamwork, Strategic Planning
Description :
Supported the daily operations of a multi-jurisdictional regulatory office, ensuring compliance with all regulatory requirements.
Assisted in the development and processing of regulatory filings and special contracts for approval by state regulatory commissions.
Ensured all filings and reports adhered to compliance guidelines and regulatory standards.
Produced correspondence, reports, spreadsheets, and contracts to support regulatory activities.
Managed departmental budgets, coordinating with relevant departments for accurate journal entries.
Facilitated the onboarding process for new employees, providing essential training on regulatory protocols.
Tracked and coordinated regulatory submissions to ensure timely approvals and compliance.
Experience
2-5 Years
Level
Management
Education
B.S. Regulatory Affairs
Associate Regulatory Coordinator Resume
Headline : Accomplished Associate Regulatory Coordinator with 7 years of expertise in regulatory submissions and compliance in clinical research. Skilled in managing complex protocols and ensuring adherence to regulatory standards. Proven ability to enhance operational efficiencies and facilitate cross-functional collaboration, driving successful outcomes in clinical trials.
Skills : Clinical Trial Management, Regulatory Protocol Development, Time Management, Attention To Detail
Description :
Oversaw regulatory submissions and ensured compliance for a diverse portfolio of clinical trials.
Collaborated with cross-functional teams to prepare and submit regulatory documents to IRB and FDA.
Monitored regulatory approvals for ongoing studies, maintaining compliance across over 120 projects.
Assisted in the development and editing of investigator-initiated and industry-sponsored research protocols.
Authored standard operating procedures to streamline clinical trial processes and enhance compliance.
Reviewed and edited NCI grant applications and annual reports to ensure regulatory alignment.
Provided mentorship to clinical trials staff on regulatory requirements and best practices.
Experience
5-7 Years
Level
Executive
Education
M.S. in RA
Regulatory Coordinator Resume
Objective : Results-oriented Regulatory Coordinator with two years of experience in ensuring regulatory compliance and managing submissions for clinical trials. Demonstrated expertise in collaborating with diverse teams to uphold regulatory standards. Passionate about streamlining processes and enhancing the integrity of clinical research through meticulous attention to detail and proactive communication.
Managed up to 75 clinical trials, ensuring all regulatory documents comply with FDA guidelines.
Created and amended informed consent forms (ICFs) according to site standards and FDA/ICH regulations.
Developed and updated site standard operating procedures (SOPs) to enhance compliance.
Collaborated with site compliance teams to verify adherence to FDA/ICH regulations.
Ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
Managed credentials for site personnel, including training and documentation.
Communicated daily with up to 35 clinical staff to facilitate regulatory processes and operations.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Assistant Regulatory Coordinator Resume
Objective : Dedicated Assistant Regulatory Coordinator with 5 years of experience in regulatory compliance and submission management within clinical research. Proven expertise in collaborating with cross-functional teams to ensure regulatory adherence and timely project execution. Committed to leveraging analytical acumen to streamline processes and enhance the quality of clinical trials.
Skills : Team Collaboration, Data Management, Regulatory Research, Regulatory Submissions, Industry Standards Knowledge, Risk Assessment
Description :
Prepared survey filings for regulatory bodies, including FDA and Environment Canada.
Reviewed international laws related to compliance in clinical research.
Substantiated marketing claims for product advertisements in compliance with regulations.
Assist in the preparation of product registration applications.
Utilized analytical skills to track and update detailed compliance risk status reports.
Collaborated with product development teams to ensure international registration compliance.
Addressed consumer inquiries related to product safety and quality assurance.
Experience
2-5 Years
Level
Executive
Education
B.S. RA
Regulatory Coordinator Resume
Objective : Results-driven Regulatory Coordinator with expertise in navigating the regulatory landscape for pharmaceuticals and medical devices. Skilled in preparing and submitting regulatory filings, conducting audits, and ensuring compliance with local and international regulations. Adept at maintaining up-to-date knowledge of regulatory changes and providing strategic guidance to cross-functional teams to facilitate product approvals.
Skills : Compliance Audits, Legal Research, Data Integrity, Regulatory Guidance, Meeting Facilitation, Standard Operating Procedures
Description :
Managed regulatory activities for clinical trials in Pediatric Oncology, ensuring compliance with relevant guidelines.
Prepared and submitted trial applications, renewals, and amendments for Institutional Review Board approval.
Coordinate with legal teams on regulatory matters and compliance issues.
Maintained regulatory files, ensuring adherence to current GCP and ICH guidelines.
Supervised daily operations of 40 clinical trials, enhancing team efficiency and project execution.
Conducted weekly team meetings to provide regulatory updates and gather feedback.
Trained temporary and contract staff on regulatory processes and documentation standards.
Experience
0-2 Years
Level
Fresher
Education
B.S. in Regulatory Affairs
Regulatory Coordinator Resume
Objective : Motivated Regulatory Coordinator with two years of experience in regulatory compliance and submission management within clinical trials. Skilled in preparing documentation and coordinating with cross-functional teams to ensure adherence to regulations and timelines. Committed to enhancing trial efficiency and regulatory processes through proactive communication and attention to detail.
Prepared protocols for IRB submissions, ensuring compliance with regulatory standards.
Oversaw retrospective chart review projects for Lipid Clinic to enhance research quality.
Assisted Research Coordinators in processing serum samples and preparing shipments to sponsors.
Coordinated regulatory submissions to ensure compliance with local and international standards.
Compiled and organized regulatory documents for the initiation of clinical trials.
Maintained up-to-date knowledge of regulatory requirements and industry trends.
Screened and consented subjects for potential enrollment in clinical trials, ensuring ethical compliance.
Experience
0-2 Years
Level
Entry Level
Education
B.S.
Regulatory Affairs Coordinator Resume
Objective : Accomplished Regulatory Affairs Coordinator with 5 years of experience in managing regulatory submissions and ensuring compliance across clinical trials. Demonstrates strong analytical skills and a deep understanding of regulatory frameworks. Proven ability to collaborate effectively with cross-functional teams to drive project success and enhance operational efficiency in clinical research.
Implemented effective project management strategies to ensure timely completion of regulatory submissions and compliance objectives.
Conducted thorough legal research and analysis of Federal and State regulations affecting clinical operations.
Provided regulatory guidance and support to Compliance and Legal departments to ensure adherence to industry standards.
Managed due diligence processes and state reporting, ensuring compliance with all applicable laws.
Oversaw surety bond management, reviewing regulatory changes and calculating necessary bond amounts.
Prepared and maintained documentation for state regulatory examinations, ensuring all materials were accurate and complete.
Collaborated with cross-functional teams to drive successful project outcomes and enhance operational efficiency.
Experience
2-5 Years
Level
Executive
Education
B.S. in RA
Regulatory Affairs Coordinator Resume
Objective : Proactive Regulatory Affairs Coordinator skilled in preparing and submitting regulatory documents, leading to successful product launches and maintaining compliance across multiple jurisdictions, enhancing market access.
Skills : Regulatory Compliance, Regulatory Submission Management, Data Analysis and Reporting, Project Management, Policy Development
Description :
Oversaw the preparation and management of regulatory submissions ensuring compliance with industry standards.
Collaborated with cross-functional teams to align project timelines and regulatory requirements.
Maintained comprehensive project calendars, tracking progress and ensuring timely submissions.
Ensured all regulatory documentation met compliance standards, including audits and inspections.
Prepared detailed reports on regulatory activities and project statuses for senior management.
Enhanced communication protocols within teams to improve operational efficiency.
Developed training sessions for staff on regulatory requirements and best practices.
Experience
2-5 Years
Level
Executive
Education
B.S. Biology
Regulatory Affairs Coordinator Resume
Objective : Accomplished Regulatory Affairs Coordinator with 5 years of experience in managing regulatory submissions and ensuring compliance with FDA standards. Proven expertise in collaborating with cross-functional teams to streamline processes and enhance operational efficiency. Committed to leveraging analytical skills to support innovative clinical research and drive successful project outcomes.
Skills : Proficient in MS Office Suite, Regulatory Compliance Expertise, Cross-Functional Collaboration, Project Management Skills, Time Management
Description :
Supported the Executive VP of Regulatory Affairs with administrative tasks and compliance documentation.
Prepared state distributor and wholesale licenses to ensure operational compliance.
Managed product complaints and returns, maintaining regulatory adherence.
Tracked and documented change control notices for regulatory submissions.
Assisted in quality assurance compliance, including investigations and reporting.
Coordinated travel arrangements and meetings for the regulatory team.
Compiled and submitted department expense reports for budget tracking.
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