What does a regulatory specialist do?
A regulatory specialist is responsible for evaluating all the business processes, functions, and requirements and ensure its compliance with the company's protocols and state regulations. Regulatory specialists conduct regular audits, review the company's documents and business transactions, renew permits and licenses, and submit necessary files required by regulatory agencies. They coordinate with the management to revise the company's handbook accordingly and disseminate information on any changes across the organization. A regulatory specialist may also facilitate training programs and orientation to inform the employees on risk policies to avoid reputational issues, potential hazards, and delays in operations.
Regulatory specialist responsibilities
Here are examples of responsibilities from real regulatory specialist resumes:
- Utilize the``SharePoint"system to manage the document change control process and maintain configuration control.
- Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
- Assess study results for adherence to 40 CFR EPA regulatory requirements.
- Stay abreast of developments in GCP and federal regulations regarding clinical research.
- Assist with QC and QA of various study relate regulatory documents and reports.
- Assist with training and mentoring of junior regulatory specialists and assist with departmental QC and QA activities.
- Serve as QA reviewer for application user manuals.
- Gain a great deal of experience with new drugs and therapies in the field of oncology.
- Improve on the strain relationship between QA and manufacturing with soft people's skills and communication.
- Document and maintain records of all complaint investigations in accordance with 21 CFR 820.198 including failure analysis follow-up.
- Develop and deliver regulatory training of safety, chemical hazards, work instructions, human resources, quality and ISO.
- Report all regulatory documentation to the appropriate IRB boards for necessary review and approvals.
- Facilitate activities surrounding institution closure, including patient transfer, study archival, and IRB notifications.
- Serve as regulatory contact person for representatives from sponsoring pharmaceutical and device firms and FDA for review of regulatory records.
- Perform quality checks to ensure compliance with FDA regulations regarding electronic submissions, and maintain expert knowledge of internal/external publishing standards.
Regulatory specialist skills and personality traits
We calculated that 10% of Regulatory Specialists are proficient in FDA, Regulatory Compliance, and Regulatory Agencies.
We break down the percentage of Regulatory Specialists that have these skills listed on their resume here:
- FDA, 10%
Served as regulatory contact person for representatives from sponsoring pharmaceutical and device firms and FDA for review of regulatory records.
- Regulatory Compliance, 8%
Reviewed commercialization plans and drug marketing advertising for compliance to regulations, assessed and reviewed regulatory compliance to safety surveillance regulation.
- Regulatory Agencies, 7%
Ensured the timely and accurate completion of all medical records documentation requirements by regulatory agencies, specific to the Medical Staff.
- Regulatory Submissions, 5%
Reviewed/approved engineering change requests regarding design changes, process changes and Quality System to determine if a regulatory submission is required.
- Customer Service, 5%
Volunteered as Customer Service President for FISH Philosophy leadership responsible for maintaining a positive work environment for all staff members.
- Clinical Trials, 4%
Submitted to and obtained approvals of regulatory authorities on clinical trials conducted by Clinical Study Unit and Contract Research Organizations.
Common skills that a regulatory specialist uses to do their job include "fda," "regulatory compliance," and "regulatory agencies." You can find details on the most important regulatory specialist responsibilities below.
The three companies that hire the most regulatory specialists are:
- Wells Fargo36 regulatory specialists jobs
- Baxter International30 regulatory specialists jobs
- Bank of America21 regulatory specialists jobs
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Compare different regulatory specialists
Regulatory specialist vs. Compliance officer
A compliance officer is responsible for monitoring company operations, ensuring that all the processes and members are adhering to the regulatory and procedural policies set by the company. Compliance officers' duties also include proposing compliance programs, reviewing and updating existing company policies with management approval, taking immediate actions for policy violations, and mitigating risks. A compliance officer must have extensive knowledge of legal procedures and regulatory standards to manage and evaluate problems, providing meaningful solutions, and keep the company's positive reputation.
While similarities exist, there are also some differences between regulatory specialists and compliance officer. For instance, regulatory specialist responsibilities require skills such as "regulatory submissions," "clinical trials," "safety reports," and "medical devices." Whereas a compliance officer is skilled in "oversight," "risk management," "compliance program," and "excellent project management." This is part of what separates the two careers.
Compliance officers tend to reach similar levels of education than regulatory specialists. In fact, compliance officers are 0.5% less likely to graduate with a Master's Degree and 2.5% more likely to have a Doctoral Degree.Regulatory specialist vs. Compliance analyst
A compliance analyst is in charge of ensuring that every operation and aspect in a company or facility adheres to the laws and regulations. They are also responsible for conducting regular inspections and assessments, producing reports and presentations, disseminating necessary information and reminders, researching existing policies and laws related to the industry, and remaining updated with new regulations. Furthermore, there are instances when a compliance analyst must gather requirements and process them to receive compliance certifications from agencies.
While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that regulatory specialist responsibilities requires skills like "regulatory submissions," "clinical trials," "safety reports," and "medical devices." But a compliance analyst might use other skills in their typical duties, such as, "powerpoint," "risk assessments," "compliance issues," and "compliance program."
Compliance analysts earn similar levels of education than regulatory specialists in general. They're 1.6% less likely to graduate with a Master's Degree and 2.5% more likely to earn a Doctoral Degree.Regulatory specialist vs. Regulatory affairs manager
A regulatory affairs manager is in charge of ensuring that all aspects of a company adhere to the rules and regulations set by regulatory agencies. Their responsibilities revolve around devising regulation compliance strategies, creating training and orientation programs to inform the staff on the policies and standards, conducting internal inspections and information drives, and keeping abreast with the latest rules and regulations. Moreover, a regulatory affairs manager is in charge of processing and submitting necessary documents to government agencies, ensuring compliance and timeliness.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a regulatory specialist is likely to be skilled in "customer service," "safety reports," "excellent organizational," and "consent forms," while a typical regulatory affairs manager is skilled in "regulatory affairs," "global regulatory," "regulatory strategies," and "project management."
When it comes to education, regulatory affairs managers tend to earn higher degree levels compared to regulatory specialists. In fact, they're 5.2% more likely to earn a Master's Degree, and 5.0% more likely to graduate with a Doctoral Degree.Regulatory specialist vs. Compliance specialist
The role of compliance specialists is to ensure that companies comply with relevant industry standards and regulations. Their duties may vary depending on the industry they work in, such as healthcare or banking. Tasks include reviewing their company's business practices to ensure they follow specific regulations, resolving compliance issues that may arise, and being up-to-date with regulatory changes. As a compliance specialist, you should have industry expertise, in-depth knowledge of regulations, and auditing skills.
Types of regulatory specialist
Updated January 8, 2025
