Regulatory Specialist: Job Duties, Skills and Salary 2025

What does a Regulatory Specialist do?

A Regulatory Specialist ensures that a company’s products and practices comply with government regulations and industry standards. They handle the preparation and submission of regulatory documents, monitor compliance with laws and regulations, and work closely with regulatory agencies to address any issues or changes in regulations. This role is critical in industries such as pharmaceuticals, healthcare, and manufacturing.

Regulatory Specialist: Main duties

Regulatory Specialists in the Healthcare field handle essential tasks and contribute significantly to achieving team and organizational goals. Here are some of their primary responsibilities:

Prepare and submit regulatory documents and applications.
Monitor and ensure compliance with industry regulations and standards.
Communicate with regulatory agencies to address compliance issues.
Review and interpret regulatory guidelines and requirements.
Maintain up-to-date knowledge of changes in regulations and industry trends.

Regulatory Specialist: Key Qualifications

Bachelor’s degree in a relevant field such as regulatory affairs, life sciences, or engineering.
Experience in regulatory affairs or a related field.
Knowledge of relevant regulations and compliance requirements.
Strong analytical and problem-solving skills.
Excellent communication and organizational skills.

Basic Skills and Requirements for Regulatory Specialists

In-depth knowledge of regulatory standards and procedures.
Strong analytical skills and attention to detail.
Effective communication and negotiation abilities.
Proficiency in regulatory documentation and compliance software.
Ability to interpret and apply complex regulatory guidelines.

Salary Expectations for Regulatory Specialists

Job	Branch	Avg. US Salary
Regulatory Specialist	Healthcare	89,000 USD

The average salary for a Regulatory Specialist in the U.S. is approximately $89,000 per year and can vary from entry-level to senior positions. Regulatory Specialists may receive a wide range of benefits.

Level	Experience	Avg. Salary per Year
Veteran	20+ years	$111,250
Senior	11+ years	$97,900
Experienced	6-10 years	$89,000
Mid Level	3-5 years	$80,100
Entry Level	0-2 years	$66,750

To explore more detailed salary information, including specific salary estimates in your country, visit the Regulatory Specialist Salary Country Overview.

Career Path for Regulatory Specialists

Regulatory Specialists typically start with a bachelor's degree and gain experience in regulatory affairs or related fields. Entry-level positions may include roles such as Regulatory Affairs Assistant or Compliance Coordinator. With experience, professionals can advance to roles such as Senior Regulatory Specialist, Regulatory Manager, or Director of Regulatory Affairs.

Additional certifications in regulatory affairs or specialized training can further enhance career opportunities and advancement.

Regulatory Specialist: Work Environment

Regulatory Specialists work in various industries, including pharmaceuticals, healthcare, biotechnology, and manufacturing. They are often employed in corporate offices, regulatory agencies, or consultancy firms.

The role involves extensive documentation and communication with regulatory bodies, often requiring adherence to strict deadlines and regulatory guidelines. While standard business hours are common, some flexibility may be needed to manage urgent compliance issues or regulatory submissions.

Regulatory Specialist: Job Duties, Skills and Salary 2025

Understand the responsibilities and career path of a Regulatory Specialist. Learn about the skills needed and the work environment for ensuring regulatory adherence and compliance.