What does a regulatory affairs associate do?
A regulatory affairs associate is in charge of learning and implementing company policies and government regulations, ensuring compliance in every aspect of the company. Their responsibilities revolve around coordinating with different departments to gather data, conducting inspections and assessments, reviewing existing procedures, liaising with external agencies, and producing progress reports. They may also participate in instructing employees of the standards one must uphold. Furthermore, as a regulatory affairs associate, it is essential to develop guidelines and standards on every procedure in adherence to the latest policies and regulations.
Regulatory affairs associate responsibilities
Here are examples of responsibilities from real regulatory affairs associate resumes:
- Manage CQA vendor deliverables and liaise with vendors to identify and remedy GCP compliance issues with active sites.
- Manage the compliance education tracking and documentation process for international GMP education.
- Manage eCTD submission preparation by negotiating data requirements and deliverable dates with internal technical teams.
- Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
- Develop all require QMS procedures complying the requirements of 21 CFR 820 and ISO 13485.
- Help prepare & maintain FDA submit regulatory documents with a team of others, as well as place them in eCTD.
- Provide operational support for all U.S., Canada and EU regulatory submission activities.
- Prepare 20 templates of drug product and filling of 300 drugs to EU countries.
- Perform gap analysis between ISO 13485 and Canadian MDR requirements and present to RA team.
- Conduct OSHA safety training, implement safety procedures, and equipment safeguarding methods.
- Supervise the implementation of a pharmacist education program and meet FDA require timetable for implementation.
- Review and prepare documents in compliance with FDA and foreign regulations for an international dental supply manufacturer.
- Reviewed/Approve change controls for CMC changes supporting manufacturing and testing sites, assess regulatory impact and determine reporting strategy.
- Review proposed chemistry, manufacturing, and control (CMC) modifications and summarize regulatory significance of changes across products.
- Review MSDS documentation to ensure data is accurate and complete.
Regulatory affairs associate skills and personality traits
We calculated that 12% of Regulatory Affairs Associates are proficient in Regulatory Affairs, FDA, and Regulatory Submissions.
We break down the percentage of Regulatory Affairs Associates that have these skills listed on their resume here:
- Regulatory Affairs, 12%
Developed procedures to ensure regulatory compliance, and supporting the extended Regulatory Affairs team with preparation of regulatory filling and amendments.
- FDA, 9%
Reviewed and prepared documents in compliance with FDA and foreign regulations for an international dental supply manufacturer.
- Regulatory Submissions, 8%
Format documents intended for regulatory submissions in accordance with company style manual to ensure they meet requirements for electronic submissions.
- Medical Devices, 6%
Authored regulatory opinion white paper to determine the best regulatory route for medical devices seeking approval prior to commercialization.
- Global Regulatory, 5%
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and a broad understanding of the global regulatory environment.
- Regulatory Agencies, 4%
Support efforts per the direction of the international regulatory agencies, sister companies and international distributors regarding registrations and licenses.
Most regulatory affairs associates use their skills in "regulatory affairs," "fda," and "regulatory submissions" to do their jobs. You can find more detail on essential regulatory affairs associate responsibilities here:
The three companies that hire the most regulatory affairs associates are:
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Compare different regulatory affairs associates
Regulatory affairs associate 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.
These skill sets are where the common ground ends though. The responsibilities of a regulatory affairs associate are more likely to require skills like "regulatory affairs," "regulatory submissions," "medical devices," and "global regulatory." On the other hand, a job as a compliance coordinator requires skills like "customer service," "patients," "powerpoint," and "compliance issues." As you can see, what employees do in each career varies considerably.
Compliance coordinators tend to reach lower levels of education than regulatory affairs associates. In fact, compliance coordinators are 7.2% less likely to graduate with a Master's Degree and 2.7% less likely to have a Doctoral Degree.Regulatory affairs associate 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.
Each career also uses different skills, according to real regulatory affairs associate resumes. While regulatory affairs associate responsibilities can utilize skills like "regulatory affairs," "regulatory submissions," "medical devices," and "global regulatory," compliance auditors use skills like "audit findings," "compliance audits," "audit reports," and "audit results."
Average education levels between the two professions vary. Compliance auditors tend to reach lower levels of education than regulatory affairs associates. In fact, they're 6.0% less likely to graduate with a Master's Degree and 2.7% less likely to earn a Doctoral Degree.Regulatory affairs associate 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.
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from regulatory affairs associate resumes include skills like "regulatory affairs," "regulatory submissions," "medical devices," and "global regulatory," whereas a compliance specialist is more likely to list skills in "patients," "strong analytical," "customer service," and "powerpoint. "
When it comes to education, compliance specialists tend to earn lower degree levels compared to regulatory affairs associates. In fact, they're 6.0% less likely to earn a Master's Degree, and 0.2% less likely to graduate with a Doctoral Degree.Regulatory affairs associate 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 associate
Updated January 8, 2025
