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Regulatory specialist skills for your resume and career

Updated January 8, 2025
7 min read
Below we've compiled a list of the most critical regulatory specialist skills. We ranked the top skills for regulatory specialists based on the percentage of resumes they appeared on. For example, 10.3% of regulatory specialist resumes contained fda as a skill. Continue reading to find out what skills a regulatory specialist needs to be successful in the workplace.

15 regulatory specialist skills for your resume and career

1. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how regulatory specialists use fda:
  • Served as regulatory contact person for representatives from sponsoring pharmaceutical and device firms and FDA for review of regulatory records.
  • Developed automated tools for ensuring compliance of closed complaints to FDA regulations and organizational procedures.

2. Regulatory Compliance

Here's how regulatory specialists use regulatory compliance:
  • Reviewed commercialization plans and drug marketing advertising for compliance to regulations, assessed and reviewed regulatory compliance to safety surveillance regulation.
  • Research regulatory compliance inquiries as required, including review and analysis of acquisition due diligence and in response to alleged violations.

3. Regulatory Agencies

A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.

Here's how regulatory specialists use regulatory agencies:
  • Ensured the timely and accurate completion of all medical records documentation requirements by regulatory agencies, specific to the Medical Staff.
  • Handled communication between projects regulatory team and Russian regulatory agencies, Russian design institutes, module fabricators and subcontractors.

4. Regulatory Submissions

Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.

Here's how regulatory specialists use regulatory submissions:
  • Reviewed/approved engineering change requests regarding design changes, process changes and Quality System to determine if a regulatory submission is required.
  • Work with regulatory team members to secure authorization of regulatory documents and in preparation of regulatory submissions per work instructions.

5. Customer Service

Customer service is the process of offering assistance to all the current and potential customers -- answering questions, fixing problems, and providing excellent service. The main goal of customer service is to build a strong relationship with the customers so that they keep coming back for more business.

Here's how regulatory specialists use customer service:
  • Volunteered as Customer Service President for FISH Philosophy leadership responsible for maintaining a positive work environment for all staff members.
  • Serve as a primary customer service contact for clients and clinical investigative sites and contribute directly to operational objectives.

6. Clinical Trials

Here's how regulatory specialists use clinical trials:
  • Submitted to and obtained approvals of regulatory authorities on clinical trials conducted by Clinical Study Unit and Contract Research Organizations.
  • Drafted physician contracts with outside counsel to promote clinical trials and define expectations for physician compensation.

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7. Safety Reports

Here's how regulatory specialists use safety reports:
  • Compile all Close-Out documents and ensure all IND Safety Reports have been acknowledged by the IRB.
  • Submit all IND Safety Reports and Serious Adverse Event Reports (SAE) to the IRB's.

8. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how regulatory specialists use medical devices:
  • Ensured proper compliance processing of Control and Qualification Evaluations on medical devices.
  • Performed regulatory research projects related to beverages, food, medical devices, cosmetics, and drugs.

9. Informed Consent

Here's how regulatory specialists use informed consent:
  • Assisted in protocol editing, source document development, Informed Consent Form review and regulatory document collection for Investigator Initiated trials.
  • Reviewed Informed consents and regulatory packages for various projects ensuring sponsor templates were implemented.

10. EU

Here's how regulatory specialists use eu:
  • Assist in preparing technical submissions for EU (CE Mark) and U.S. marketing authorizations.
  • Maintained the EU CHMP Submission Requirements and Contact information table.

11. Management System

A management system is a set of policies, processes, and procedures taken by an organization or a business to ensure it can fulfill its tasks and achieve its objectives. A management system makes sure that the company excels financially and improves the user experience. The management system also takes care of the worker's and employees' needs and manages their workload and oversees their performance. Apart from interior matters of the company, a management system also deals with exterior matters like legislations, tax matters, and law issues.

Here's how regulatory specialists use management system:
  • Worked with transferring the operation and maintenance responsibilities regarding storm water management systems for commercial, industrial and residential real estate.
  • Served as core team member for development/implementation of chemical approval and MSDS management system.

12. GCP

Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.

Here's how regulatory specialists use gcp:
  • Certified for GCP, HIPAA and CITI Human Subject Training for Researchers Assignments vary based on department and/or functional area.
  • Report SAE's, deviations to the IRB in a timely manner as outlined in the GCP ICH guidelines.

13. Federal Regulations

Federal regulations refer to the set of rules, both general and permanent that are published in the Federal Register by the agencies of the federal government and the executive departments. Federal regulations are the large body of rules that govern federal practice. Examples of these laws include taxes and financial regulation, discrimination law, wages law, and so on.

Here's how regulatory specialists use federal regulations:
  • Analyzed, troubleshoot and resolved complex problems according to federal regulations.
  • Secured compliance of federal regulations for investigators and Institutional compliance.

14. Consent Forms

Consent forms refer to something that a person signs or attests to in order to agree for something that involves them to happen. They are used in various fields and applications. It is a legal document that can have repercussions if forged or denied later. In medical terms, it is the informed consent of the patient agreeing to the medical procedure they are about to undergo in a sound state of mind.

Here's how regulatory specialists use consent forms:
  • Prepared study-specific consent forms using IRB approved template.
  • Track and document all Duke Institutional Review Board (IRB) approvals including consent forms and protocol amendments.

15. ISO

Here's how regulatory specialists use iso:
  • Developed and delivered regulatory training of safety, chemical hazards, work instructions, human resources, quality and ISO.
  • Monitored evolution of ISO manuals, guidelines, and policies and implemented necessary modifications to NERC Compliance Program.
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List of regulatory specialist skills to add to your resume

Regulatory specialist skills

The most important skills for a regulatory specialist resume and required skills for a regulatory specialist to have include:

  • FDA
  • Regulatory Compliance
  • Regulatory Agencies
  • Regulatory Submissions
  • Customer Service
  • Clinical Trials
  • Safety Reports
  • Medical Devices
  • Informed Consent
  • EU
  • Management System
  • GCP
  • Federal Regulations
  • Consent Forms
  • ISO
  • Regulatory Support
  • Regulatory Guidance
  • Regulatory Issues
  • Data Entry
  • Regulatory Guidelines
  • CMS
  • PI
  • Oncology
  • CFR
  • OSHA
  • EPA
  • QC
  • QA
  • Medicaid
  • SharePoint
  • CMC
  • HIPAA
  • Regulatory Review
  • Lifecycle Management
  • GMP
  • Internal Audit
  • ECTD
  • FCC
  • State Regulations
  • CAPA
  • CRO
  • Real Estate
  • Investigative Sites
  • FAA
  • ICH Guidelines
  • ICF
  • Clinical Studies

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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