What does a regulatory affairs specialist do?
A regulatory affairs specialist assists in securing and maintaining government approval for nutritional products, drugs, medical devices, and related supplies. They are often employed by medical, pharmaceutical, and biotechnology companies. They may also work in the government or law. Typically, they work on document preparation, file maintenance, information management, and coordination of tasks across various departments. They expanded their duties and responsibilities as a result of company acquisitions and restructuring, worldwide globalization of markets, and constantly evolving regulations.
Regulatory affairs specialist responsibilities
Here are examples of responsibilities from real regulatory affairs specialist resumes:
- Gather, evaluating, organizing, managing and collating information in a variety of formats.
- Manage CRO (regulatory) in support of the company's approve product in Europe.
- Manage and submit electronic EPA product registrations.
- Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
- Support complaint handling process and screening, ensure FDA 21 CFR compliance.
- Close complaints receive from external customers in compliance with FDA, ISO, QSR and other regulatory guidelines.
- Maintain FDA and GCP require regulatory documentation ensuring compliance.
- Support the preparation and submission of regulatory documentation to health authorities for the development of investigational oncology products.
- Contribute to the FDA regulatory submission process through authoring and/or publishing electronic submissions for trauma reconstructive orthopedic medical devices.
- Assist with PMA annual reports.
- Support labeling section of PMA submission.
- Train on the FDA s STED pilot program and beginning eCTD filing.
- Work with cross functional groups to discuss product hazardous warning labels and ISO standards.
- Maintain all state and EPA regulatory, as well as MSDS and product labels.
- Prepare state and federal medical device licensing, establishment registration and listings, MDR reporting.
Regulatory affairs specialist skills and personality traits
We calculated that 10% of Regulatory Affairs Specialists are proficient in Regulatory Affairs, FDA, and Regulatory Agencies.
We break down the percentage of Regulatory Affairs Specialists that have these skills listed on their resume here:
- Regulatory Affairs, 10%
Provide strategic direction and operational management of the Regulatory Affairs and Compliance staff in order to successfully navigate the regulatory process.
- FDA, 8%
Work collaboratively with the Purchasing Department to review raw material specifications and FDA declarations from suppliers to assist in approving suppliers.
- Regulatory Agencies, 7%
Interacted with International affiliates/Distributors and representatives of regulatory agencies.
- Medical Devices, 6%
Evaluate the compatibility of trauma reconstructive orthopedic medical devices across multiple device classes and product lines.
- Regulatory Compliance, 5%
Review and approve device labeling as well as scientific and promotional materials; also documentation change requests to ensure regulatory compliance.
- Regulatory Submissions, 5%
Participate in decision making on regulatory submission issues using historical knowledge and FDA's current regulations on medical device industry.
"regulatory affairs," "fda," and "regulatory agencies" are among the most common skills that regulatory affairs specialists use at work. You can find even more regulatory affairs specialist responsibilities below, including:
The three companies that hire the most regulatory affairs specialists are:
- Baxter International73 regulatory affairs specialists jobs
- Pharmaceutical Product Development
66 regulatory affairs specialists jobs
- Highmark47 regulatory affairs specialists jobs
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Compare different regulatory affairs specialists
Regulatory affairs specialist vs. Compliance coordinator
A compliance coordinator specializes in ensuring that every aspect of a company adheres to its policies and regulations, including the state laws. Their responsibilities revolve around maintaining an active communication line with different departments to gather and analyze data, identifying vulnerable areas and risks, conducting internal investigations and inspections on compliance violations, assessing workforce performance, and reviewing product and systems documentation. Furthermore, it is essential to gather compliance certifications or data, all while reporting to the risk committee, managers, and other high-ranking officials.
While similarities exist, there are also some differences between regulatory affairs specialists and compliance coordinator. For instance, regulatory affairs specialist responsibilities require skills such as "regulatory affairs," "medical devices," "regulatory submissions," and "excellent interpersonal." Whereas a compliance coordinator is skilled in "customer service," "powerpoint," "compliance program," and "osha." This is part of what separates the two careers.
Compliance coordinators tend to reach similar levels of education than regulatory affairs specialists. In fact, compliance coordinators are 4.3% less likely to graduate with a Master's Degree and 2.5% less likely to have a Doctoral Degree.Regulatory affairs specialist vs. Compliance auditor
A compliance auditor is responsible for reviewing the company's policies and procedures, ensuring the organization's adherence to state and federal regulations. Compliance auditors inspect the operations of each department, adjusting internal guidelines as needed. They also inspect the condition of all facilities, including tools and equipment, network systems, and business operations. A compliance auditor mitigates risks by analyzing the operational processes and conducting a risk assessment study to prevent compliance issues that may pose a negative effect on the company's performance and stability.
While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that regulatory affairs specialist responsibilities requires skills like "regulatory affairs," "medical devices," "regulatory submissions," and "excellent interpersonal." But a compliance auditor might use other skills in their typical duties, such as, "audit findings," "compliance audits," "audit reports," and "audit results."
Average education levels between the two professions vary. Compliance auditors tend to reach similar levels of education than regulatory affairs specialists. In fact, they're 3.1% less likely to graduate with a Master's Degree and 2.5% less likely to earn a Doctoral Degree.Regulatory affairs 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.
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 affairs specialist is likely to be skilled in "regulatory affairs," "medical devices," "regulatory submissions," and "patients," while a typical compliance officer is skilled in "oversight," "risk management," "compliance program," and "excellent project management."
When it comes to education, compliance officers tend to earn similar degree levels compared to regulatory affairs specialists. In fact, they're 1.7% less likely to earn a Master's Degree, and 1.0% less likely to graduate with a Doctoral Degree.Regulatory affairs 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.
Types of regulatory affairs specialist
Updated January 8, 2025
