Regulatory Affairs Coordinator Job Description [Updated for 2025]

In the era of stringent compliance and regulatory environments, the focus on Regulatory Affairs Coordinators has become paramount.

Regulations evolve, and with each change, the need for skilled professionals who can interpret, manage, and ensure compliance with these regulations grows stronger.

But let’s delve deeper: What’s really expected from a Regulatory Affairs Coordinator?

Whether you are:

• A job seeker trying to understand the core of this role,
• A hiring manager outlining the perfect candidate,
• Or simply curious about the intricacies of regulatory affairs coordination,

You’re in the right place.

Today, we present a customizable Regulatory Affairs Coordinator job description template, designed for effortless posting on job boards or career sites.

Let’s get started.

Regulatory Affairs Coordinator Duties and Responsibilities

Regulatory Affairs Coordinators work in sectors such as pharmaceuticals, medical devices, energy, and banking, ensuring that the company complies with all the regulations and laws pertaining to their business.

Their main role is to ensure that the company’s products comply with regulations in all the countries where they wish to distribute them.

Their duties and responsibilities include:

• Coordinate, prepare, or review regulatory submissions for domestic or international projects
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
• Advise project teams on subjects such as premarket regulatory requirements, export and import requirements, or clinical study compliance issues
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
• Coordinate efforts associated with the preparation of regulatory documents or submissions
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance

 

Regulatory Affairs Coordinator Job Description Template

Job Brief

We are seeking a detail-oriented Regulatory Affairs Coordinator to assist with the preparation, submission, and management of documents and procedures pertaining to regulatory compliance.

The ideal candidate will have a strong understanding of regulatory guidelines and standards in our industry, as well as excellent communication skills.

Responsibilities will include maintaining regulatory documents, coordinating with departments for necessary information and assistance, and ensuring compliance with regulatory standards.

 

Responsibilities

• Prepare and submit regulatory documents in compliance with applicable guidelines.
• Maintain accurate and up-to-date regulatory files and databases.
• Coordinate with different departments to gather required information.
• Review and update company practices in accordance with regulatory changes.
• Participate in regulatory audits and inspections.
• Facilitate communication between the organization and regulatory authorities.
• Develop and implement strategies for regulatory approvals.
• Assist in the development and review of company policies and procedures.
• Support and advise on regulatory affairs.
• Track and report on the progress of regulatory submissions.

 

Qualifications

• Bachelor’s degree in Life Sciences, Law, Business Administration, or a related field.
• Previous experience in regulatory affairs or a related field.
• Knowledge of regulatory guidelines and standards.
• Strong organizational and coordination skills.
• Excellent written and verbal communication skills.
• Detail-oriented with a high degree of accuracy.
• Ability to manage multiple projects and meet deadlines.
• Proficiency in Microsoft Office Suite, especially Excel.

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Regulatory Affairs Coordinator
• Work Environment: Office setting with options for remote work. Occasional travel may be required for regulatory meetings or seminars.
• Reporting Structure: Reports to the Regulatory Affairs Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $60,000 minimum to $85,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Regulatory Affairs Coordinator Do?

A Regulatory Affairs Coordinator typically works for organizations in highly regulated industries such as pharmaceutical, medical device, or biotechnology companies.

They may also work for regulatory agencies or consultancy firms specializing in regulatory affairs.

Their primary role is to ensure that their company complies with all the regulations and laws pertaining to their business.

This includes coordinating and documenting all regulatory processes, such as audits, inspections, licenses, or registrations.

They work closely with various department heads to review and prepare regulatory documents required for product approvals or renewals.

This may also involve preparing and submitting documentation to regulatory agencies, responding to requests for additional information, and tracking the progress of submissions.

Regulatory Affairs Coordinators must keep abreast of regulatory news and updates to understand the potential impact on their organization.

They often have to interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Furthermore, they are responsible for developing regulatory strategies and update systems used for tracking and regulatory information.

They also coordinate regulatory training for other employees to ensure a comprehensive understanding of compliance requirements throughout the organization.

 

Regulatory Affairs Coordinator Qualifications and Skills

A competent Regulatory Affairs Coordinator should possess the skills and qualifications that align with the job description, such as:

• Thorough knowledge of regulatory affairs and industry regulations to ensure company compliance with all laws, regulations, and policies.
• Strong research skills to stay informed about changing industry regulations and impact on the business.
• Excellent communication skills to clearly explain regulatory information to other employees and stakeholders within the company.
• Problem-solving skills to assess and resolve compliance issues and to develop strategies to avoid future compliance issues.
• Detail-oriented nature to ensure accuracy in document preparation and the review process.
• Ability to manage multiple tasks and projects simultaneously to meet deadlines.
• Strong interpersonal skills for collaboration with various departments within the company.
• Experience in preparing regulatory documentation and submissions.
• Understanding of good manufacturing practices (GMP) and other relevant industry standards.

 

Regulatory Affairs Coordinator Experience Requirements

For the role of Regulatory Affairs Coordinator, the experience requirements can vary based on the industry and the complexity of the role.

However, candidates generally need at least two to four years of experience in regulatory affairs or a related area such as quality assurance or compliance.

Entry-level candidates for the role may have gained experience through internships or part-time roles in regulatory affairs departments, or through roles that required them to interact with regulatory bodies.

This could be within the pharmaceutical, medical device, biotechnology, food and beverage, or other regulated industries.

Candidates with over three years of experience usually have more in-depth knowledge of regulatory processes and guidelines, and may have had exposure to international regulatory procedures.

They could have held roles such as Regulatory Affairs Associate or Specialist.

Candidates with over five years of experience often possess a proven track record of successfully coordinating regulatory submissions and maintaining compliance documentation.

Such candidates may have held leadership roles in their previous positions, and they are likely ready to manage a team or take on more complex regulatory projects.

Moreover, experience with specific regulatory frameworks (like FDA regulations in the US, EMA in Europe, etc.) can be highly beneficial.

Candidates should ideally also have strong communication and organizational skills, as well as an ability to understand and interpret regulatory legislation.

 

Regulatory Affairs Coordinator Education and Training Requirements

Regulatory Affairs Coordinators are typically required to have a bachelor’s degree in a life science, healthcare, or a related field.

They also need a strong understanding of national and international regulatory requirements and procedures.

In addition to the bachelor’s degree, experience in regulatory affairs, clinical research, or quality assurance is usually required.

Some employers may prefer candidates with a master’s degree in regulatory affairs, pharmaceutical sciences, or a related field.

Certifications such as the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society can enhance job prospects.

It is also beneficial to have knowledge about regulatory guidelines like FDA, EMA, and ICH.

Continual professional development is important in this field due to changing regulations and procedures.

Thus, an ongoing commitment to learning and staying updated with industry changes is expected.

 

Regulatory Affairs Coordinator Salary Expectations

A Regulatory Affairs Coordinator earns an average salary of $67,290 (USD) per year.

The actual earnings can vary based on experience, industry, geographical location, and the size of the company.

 

Regulatory Affairs Coordinator Job Description FAQs

What skills does a Regulatory Affairs Coordinator need?

Regulatory Affairs Coordinators should have strong organizational skills to manage and prioritize multiple tasks.

They should possess excellent attention to detail to ensure compliance with regulations.

Good communication and interpersonal skills are necessary for liaising with various departments and external regulatory bodies.

Knowledge in regulatory guidelines and standards is also crucial.

 

Do Regulatory Affairs Coordinators need a specific degree?

Typically, a Regulatory Affairs Coordinator needs a degree in fields such as Law, Business Administration, Life Sciences, or a related field.

Some roles might prefer candidates with a Master’s degree or specific certifications in regulatory affairs.

Relevant experience in regulatory affairs or a similar field is often valued highly.

 

What should you look for in a Regulatory Affairs Coordinator resume?

Look for a solid background in regulatory affairs or related roles.

Knowledge and understanding of regulatory standards and guidelines should be evident.

Evidence of strong organizational and communication skills is important.

Also, look for any specific certifications or qualifications in regulatory affairs.

Experience in the industry relevant to your company (e.g., pharmaceuticals, medical devices) can be a huge plus.

 

What qualities make a good Regulatory Affairs Coordinator?

A good Regulatory Affairs Coordinator is thorough, detail-oriented, and organized.

They should be able to manage multiple tasks and projects, often with tight deadlines.

Strong communication skills are vital, as they will often be liaising with various departments and external regulatory bodies.

They should also be proactive in staying up-to-date with changes in regulatory standards and guidelines.

 

Is it difficult to hire Regulatory Affairs Coordinators?

Hiring Regulatory Affairs Coordinators can be challenging due to the need for specific knowledge and experience in regulatory affairs.

Candidates must understand the industry’s regulatory landscape and be able to interpret and apply complex regulations.

As such, it may take time to find a candidate with the right combination of qualifications, experience, and skills.

 

Conclusion

There you have it.

Today, we’ve demystified the ins and outs of being a Regulatory Affairs Coordinator.

Surprise, surprise!

It’s not just about managing compliances.

It’s about shaping the legal and ethical backbone of a company, one regulation at a time.

With our handy Regulatory Affairs Coordinator job description template and real-world examples, you’re ready to step up to the plate.

But why stop at that?

Dive deeper with our job description generator. It’s your springboard to creating razor-sharp listings or honing your resume to perfection.

Remember:

Every regulation managed is a step towards a compliant and effective business.

Let’s shape that future. Together.

How to Become a Regulatory Affairs Coordinator (Complete Guide)

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