Regulatory Affairs Specialist Job Description, Key Duties and Responsibilities

Regulatory Affairs Specialist Job Description, Key Duties and Responsibilities

This post provides complete information on the job description of a regulatory affairs specialist, to help increase your knowledge of what they do.

It highlights the key duties, tasks, and responsibilities that commonly make up the regulatory affairs specialist work description in most organizations.

It also presents the major requirements recruiters may want you to meet to be hired as a regulatory affairs specialist.

Please, continue reading to learn more about the regulatory affairs specialist career:

What Does a Regulatory Affairs Specialist Do?

A regulatory affairs specialist is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under certain regulations.

The regulatory affairs specialist work description entails assisting in obtaining and maintaining government approval for materials such as drugs, medical devices, nutritional products, and several other related materials.

A regulatory affairs specialist is often employed or usually works in biotechnology, pharmaceutical, and medical device companies.

He/she may also work in government or law.

Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies.

They are often responsible for executing several important duties as a result of continuous and constantly evolving regulations worldwide.

A regulatory affairs specialist typically works within an office of regulatory affairs where he/she is responsible for working on the preparation of documents, management of information, maintenance of files, and coordination of tasks across multiple departments.

He/she also has to strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.

He/she is also expected to understand and be familiar with all aspects of product development, which may include clinical trials, research, manufacturing practices, regulations, and approval processes.

The regulatory affairs specialist work description also involves advising project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.

It also includes determining the types of regulatory submissions or internal documentation that are needed in situations like labeling changes or proposed device changes.

The ideal candidate who wants to work in the position of a regulatory affairs specialist is expected to possess and demonstrate several important skills or attributes, such as the ability to work effectively in a demanding environment, effective communication, and interpersonal skills.

He/she should also possess ability to pay particular attention to details, excellent organizational skills, good project management skills, proficiency and familiarity with databases.

In terms of academic qualifications, the position of a regulatory affairs specialist requires the ideal candidate to possess sound and adequate educational background, as he/she is required to possess a Bachelor’s degree in fields such as Biochemistry, Biological Sciences, Chemistry, Pharmacy, Toxicology, Medicine, Pharmacology, or Engineering.

A coursework in Marketing, Law, Statistics, and Business can also be useful.

Some employers also demand several years of proven work experience in a similar industry.

Regulatory affairs specialist salary: The average annual salary for a regulatory affairs specialist is $68,294.

Regulatory Affairs Specialist Job Description Example/Sample/Template

The major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below:

Explaining regulations, policies, or procedures
Ensuring adequate compliance with regulations
Advising others on matters that are related to regulatory processes and compliance
Providing correct and accurate technical review of data or reports
Overseeing the planning, coordination, and management of regulatory documentation activities
Examining, identifying, and interpreting relevant regulatory guidelines
Analyzing and evaluating laws and regulations that apply to the process of determining the impact on company activities
Compiling and overseeing the maintenance of regulatory documentation databases or systems
Coordinating efforts that are related to the preparation of regulatory documents or submissions
Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.

Regulatory Affairs Specialist Job Description for Resume

If you have worked before as a regulatory affairs specialist or are presently working in that position and need to make a new resume, then it is important to include a professional experience section to the resume to highlight your duties on the regulatory affairs specialist job.

The sample job description provided above can help you to effectively describe your regulatory affairs specialist role in the professional or work experience section of your resume.

Regulatory Affairs Specialist Requirements – Skills, Knowledge, and Abilities for Career Success

If you are seeking to work as a regulatory affairs specialist, here are major requirements most recruiters may want you to meet to be hired:

Good time management skills, as a regulatory affairs specialist, must be able to work effectively in a demanding environment where strict timelines and protocols must be met
Proficiency and familiarity with databases or other information management tools, since regulatory affairs specialists frequently work on managing and documenting information
Excellent organizational and project management skills to frequently coordinate complex activities, often with competing priorities
Well-developed analytical skills and the ability to pay particular attention to details
Well-developed written and oral communication and interpersonal skills to frequently work with other employees and team members, and also advise others on compliance and regulatory matters
A Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, or Pharmacology.

Conclusion

If you are a recruiter of HR manager needing to hire for the regulatory affairs specialist position in your organization, you will have to create and post a detailed description of the vacant regulatory affairs specialist position to inform prospective candidates of what the role entails.

You can apply the above job description example as a template to effectively describe the available regulatory affairs specialist role in your organization, which will increase your chances of getting the right persons for the job.

This article is also useful to individuals interested in the regulatory affairs specialist career to increase their knowledge of the duties associated with the role.