Medical and Regulatory Reviewer Job Description [Updated for 2025]

In the evolving world of healthcare, the role of Medical and Regulatory Reviewers has become increasingly significant.

Medical advancements and regulatory changes forge ahead, and with each progression, the demand for proficient individuals who can navigate, interpret, and implement these complex standards escalates.

But let’s delve deeper: What’s really expected from a Medical and Regulatory Reviewer?

Whether you are:

• A job seeker trying to understand the core responsibilities of this role,
• A hiring manager outlining the ideal candidate profile,
• Or simply fascinated by the intricacies of medical and regulatory reviewing,

You’ve come to the right place.

Today, we present a versatile Medical and Regulatory Reviewer job description template, tailored for effortless posting on job boards or career sites.

Let’s dive in.

Medical and Regulatory Reviewer Duties and Responsibilities

Medical and Regulatory Reviewers are professionals who oversee the regulatory and compliance processes within a medical or pharmaceutical context.

They are responsible for ensuring that all medical materials and processes adhere to the regulations set forth by government and health authorities.

Their duties and responsibilities include:

• Reviewing all medical and promotional materials to ensure compliance with regulations
• Ensuring all documentation and materials meet industry standards and regulatory guidelines
• Evaluating and analyzing clinical data in medical literature and regulatory documents
• Providing regulatory guidance to teams on medical and scientific matters
• Maintaining up-to-date knowledge of laws, regulations, and policies that affect the industry
• Assisting in the development and implementation of regulatory strategies
• Communicating with regulatory authorities regarding submissions and compliance issues
• Coordinating with internal departments to ensure consistent adherence to regulations and standards
• Conducting internal audits to identify potential areas of compliance vulnerability and risk

 

Medical and Regulatory Reviewer Job Description Template

Job Brief

We are looking for a detail-oriented and knowledgeable Medical and Regulatory Reviewer to join our team.

Your responsibilities will include reviewing and assessing the validity and reliability of clinical trial data, ensuring compliance with regulatory standards and guidelines, and providing expert advice on medical and regulatory matters.

Our ideal candidate is someone who has a deep understanding of clinical trials, drug regulations, and good clinical practices.

This role requires the ability to effectively communicate and collaborate with various teams including research, medical affairs, and regulatory affairs.

 

Responsibilities

• Review and assess clinical trial data for validity and reliability
• Ensure compliance with regulatory standards and guidelines
• Provide expert advice on medical and regulatory matters
• Collaborate with various teams including research, medical affairs, and regulatory affairs
• Prepare and review regulatory submission documents
• Stay up to date with changes in regulatory legislation and guidelines
• Evaluate risks and develop mitigation strategies
• Maintain thorough knowledge of clinical trial protocols

 

Qualifications

• Proven work experience as a Medical and Regulatory Reviewer or similar role
• Deep understanding of clinical trials, drug regulations, and good clinical practices
• Excellent communication and collaboration skills
• Ability to work independently and in a team
• Attention to detail and ability to make sound decisions
• Proficiency in data analysis and reporting
• A medical degree or a degree in pharmacy, nursing, or related field

 

Benefits

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

 

Additional Information

• Job Title: Medical and Regulatory Reviewer
• Work Environment: Office setting with options for remote work. Some travel may be required for conferences or seminars.
• Reporting Structure: Reports to the Director of Medical Affairs or Regulatory Affairs Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $100,000 minimum to $150,000 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 Medical and Regulatory Reviewer Do?

Medical and Regulatory Reviewers typically work in pharmaceutical companies, healthcare organizations, or regulatory agencies.

They can also work as independent consultants.

They work closely with other medical, quality assurance, and regulatory professionals to review and evaluate scientific and medical data or documents.

Their main role is to ensure that all information, communication, and promotional materials about pharmaceutical products, medical devices, or health services comply with the regulations and guidelines established by authorities such as the FDA, EMA, and others.

They review and assess clinical data, research protocols, product labels, patient information leaflets, advertising materials, and other related documents for accuracy, adequacy, and adherence to regulatory requirements.

Medical and Regulatory Reviewers also provide strategic input during product development and marketing, ensuring that regulatory considerations are taken into account.

They may be involved in interactions with regulatory agencies, helping to prepare and submit applications for product approvals, and responding to regulatory queries or findings.

Their role is essential to ensure that patients and healthcare providers receive accurate, clear, and compliant information, and that organizations operate within the regulatory framework.

 

Medical and Regulatory Reviewer Qualifications and Skills

Medical and Regulatory Reviewers require a diverse set of skills and qualifications to ensure that medical products or interventions meet the necessary regulatory standards.

These may include:

• Knowledge of relevant medical, pharmaceutical, and regulatory terms and principles, with an ability to understand and interpret complex medical data.
• Excellent attention to detail and ability to identify potential issues in medical documentation or study reports.
• Strong analytical and critical thinking skills to analyze scientific data and evaluate its compliance with regulatory standards.
• Outstanding written and verbal communication skills to clearly convey feedback, recommendations, and complex regulatory information to a variety of stakeholders.
• Problem-solving skills to identify potential regulatory issues and propose feasible solutions.
• Interpersonal skills to collaborate effectively with cross-functional teams, including researchers, clinicians, and regulatory authorities.
• Organization skills to manage multiple projects, meet deadlines and adapt to changing priorities.
• Ability to stay current with changes in regulations and guidelines in the medical field.

 

Medical and Regulatory Reviewer Experience Requirements

Candidates for the role of Medical and Regulatory Reviewer often come from a background in healthcare, ideally with a degree in medicine, pharmacy, or a related field.

Direct experience in clinical research or pharmaceuticals is particularly beneficial, and many candidates will have spent time working in roles such as Clinical Research Associate or Regulatory Affairs Specialist.

Entry-level candidates may have 1 to 2 years of experience, often gained through an internship or part-time role in a medical, pharmaceutical, or regulatory setting.

These professionals may have performed tasks such as reviewing clinical trial data or assisting in the preparation of regulatory submission documents.

Candidates with more than 3 years of experience will have typically developed a solid understanding of medical regulations and clinical procedures.

They may have also gained experience in the interpretation and application of regulatory guidelines, as well as in the preparation and submission of regulatory documents.

Those with more than 5 years of experience are usually considered highly skilled in the medical and regulatory field.

They may have held positions of responsibility, such as leading a clinical trial or overseeing the regulatory compliance of a medical product or drug.

These candidates are often ready for senior roles, where they can use their extensive knowledge and experience to guide and influence the regulatory strategy of a healthcare company.

 

Medical and Regulatory Reviewer Education and Training Requirements

Medical and Regulatory Reviewers typically require a bachelor’s degree in life sciences, pharmacy, nursing, medicine or a related field.

In-depth knowledge of regulatory guidelines and procedures is essential, and this can be gained through experience in clinical research or regulatory affairs.

Many positions may also require a master’s degree or doctorate in a related field, especially for roles that involve reviewing complex medical data or clinical research.

Medical and Regulatory Reviewers often need to have a professional certification such as the Regulatory Affairs Certification (RAC) to demonstrate their expertise in the field.

Prior experience in medical writing, clinical trials, or pharmaceuticals can be beneficial in this role.

Continuing education is also important for staying updated with changes in regulatory guidelines and standards.

Knowledge of medical terminology and strong analytical skills are also critical for success in this role.

 

Medical and Regulatory Reviewer Salary Expectations

A Medical and Regulatory Reviewer earns an average salary of $90,000 (USD) per year.

The actual earnings can significantly vary depending on factors such as work experience, educational qualifications, the employing company, and the geographical location.

 

Medical and Regulatory Reviewer Job Description FAQs

What is the educational requirement for a Medical and Regulatory Reviewer?

A Medical and Regulatory Reviewer typically requires a bachelor’s degree in a field like biology, chemistry, pharmacology, or another related scientific field.

Many roles also require a higher degree, such as a PharmD, MD, or Ph.D. Additionally, knowledge in regulatory affairs and compliance is necessary, which can be gained through experience or through specific regulatory affairs courses or certifications.

 

What skills does a Medical and Regulatory Reviewer need?

This role requires a strong understanding of medical and regulatory requirements, excellent attention to detail, and strong analytical skills to effectively review and evaluate medical documents and data.

They must also have excellent written and verbal communication skills to effectively convey their findings and any regulatory concerns.

Being able to work in a team and under tight deadlines is also important.

 

What does a typical day look like for a Medical and Regulatory Reviewer?

The main task of a Medical and Regulatory Reviewer is to review medical data, research documents, promotional materials, and product labels to ensure compliance with regulatory standards.

They may also attend meetings with regulatory agencies, respond to regulatory authorities’ inquiries, provide regulatory guidance to teams within the company, and participate in the development of regulatory strategies.

 

What qualities make a good Medical and Regulatory Reviewer?

A good Medical and Regulatory Reviewer is meticulous, has a strong understanding of regulations and guidelines, and remains updated on the latest changes in the field.

They should have strong decision-making abilities and be able to work well under pressure.

Ethical integrity is also crucial in this role, as they are responsible for ensuring that medical products and practices comply with the necessary regulations.

 

Is it difficult to hire a Medical and Regulatory Reviewer?

Hiring a Medical and Regulatory Reviewer can be challenging due to the specific knowledge and expertise required for the role.

It is critical to find someone with the right educational background and relevant experience in medical regulation and review.

Therefore, the hiring process might take longer and require a more in-depth evaluation of candidates compared to other roles.

 

Conclusion

And there you have it.

Today, we’ve given you a behind-the-scenes look at what it really means to be a Medical and Regulatory Reviewer.

Surprise, surprise.

It’s not just about reviewing medical documentation.

It’s about safeguarding public health, one regulation at a time.

Armed with our detailed Medical and Regulatory Reviewer job description template and genuine examples, you’re ready to take the next step.

But don’t stop there.

Probe further with our job description generator. It’s your go-to tool for creating precise job listings or refining your resume to achieve perfection.

Keep in mind:

Every regulation reviewed contributes to the larger health landscape.

Let’s safeguard public health. Together.

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