Regulatory Affairs Data Manager Job Description [Updated for 2025]

In the era of strict compliance and complex regulations, the importance of Regulatory Affairs Data Managers has never been more prominent.

As the regulatory landscape evolves, the demand for skilled professionals who can manage, analyze, and ensure the integrity of regulatory data heightens.

But let’s delve deeper: What’s truly expected from a Regulatory Affairs Data Manager?

Whether you are:

• A job seeker trying to understand the core responsibilities of this role,
• A hiring manager defining the ideal candidate,
• Or simply interested in the intricacies of regulatory data management,

You’re in the right place.

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

Let’s dive right in.

Regulatory Affairs Data Manager Duties and Responsibilities

Regulatory Affairs Data Managers are responsible for managing data related to regulatory matters in a variety of industries.

Their role is crucial in ensuring compliance with local, national, and international regulations and standards.

They typically perform the following duties and responsibilities:

• Collect, organize, and maintain data for regulatory submissions
• Stay updated with regulatory laws and guidelines at local, national, and international levels
• Coordinate with different departments to gather accurate data for regulatory submissions
• Perform quality control checks to ensure accuracy and completeness of data
• Prepare reports summarizing regulatory submission data
• Interpret regulatory rules and guidelines and provide advice to the organization on compliance
• Assist in the development and implementation of regulatory strategies
• Communicate with regulatory bodies for any data-related inquiries or issues
• Participate in audits and inspections, ensuring data integrity and compliance
• Provide training and guidance to colleagues on data management in regulatory affairs

 

Regulatory Affairs Data Manager Job Description Template

Job Brief

We are seeking a detail-oriented Regulatory Affairs Data Manager to oversee all regulatory data management activities.

The responsibilities include maintaining regulatory databases, ensuring regulatory compliance, preparing reports, and supporting regulatory inspections.

The ideal candidate has a strong understanding of regulatory compliance and data management principles, as well as excellent organizational skills.

In the end, the Regulatory Affairs Data Manager should ensure the integrity, security, and effective use of our company’s regulatory data.

 

Responsibilities

• Establish and maintain regulatory databases
• Ensure data accuracy and integrity
• Review and update existing data management processes
• Develop and implement efficient data management strategies
• Support regulatory inspections and audits
• Prepare and present reports on regulatory data management activities
• Ensure compliance with regulatory requirements
• Communicate with various departments to gather and validate data
• Continually update knowledge of regulatory guidelines and industry best practices

 

Qualifications

• Proven work experience as a Regulatory Affairs Data Manager or similar role
• Knowledge of regulatory guidelines and procedures
• Proficiency in data management principles and best practices
• Familiarity with data management software and databases
• Excellent analytical and problem-solving skills
• Strong communication and presentation skills
• Attention to detail
• BSc degree in a relevant field such as Information Management, Regulatory Affairs or related field

 

Benefits

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

 

Additional Information

• Job Title: Regulatory Affairs Data Manager
• Work Environment: Office setting. Remote work may be possible depending on company policies.
• Reporting Structure: Reports to the Director of Regulatory Affairs.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: Dependent on qualifications and experience
• 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 Data Manager Do?

Regulatory Affairs Data Managers generally work for pharmaceutical companies, biotechnology firms, or other organizations involved in the development and marketing of health care products.

Their primary responsibility is to ensure that their company’s products comply with all national and international regulations, guidelines, and practices.

This includes reviewing and approving promotional material, assessing the acceptability of quality, non-clinical, and clinical documentation, and discussing regulatory issues with authorities.

They manage and maintain databases related to regulatory affairs, ensuring that the data is accurate, up-to-date and compliant.

They also generate reports and analyze data to identify trends, forecast potential issues and devise strategies.

Regulatory Affairs Data Managers often collaborate with multiple departments, including research and development, production, and marketing, to ensure that regulatory compliance is maintained throughout the product’s lifecycle.

They also keep track of changes in regulatory legislation and guidelines, advising on the legal and scientific restraints and requirements, and predicting their impact on the business.

In addition, they may be responsible for overseeing clinical trials, ensuring they are compliant with regulatory standards, and coordinating the collection and preparation of regulatory submission documents.

 

Regulatory Affairs Data Manager Qualifications and Skills

A proficient Regulatory Affairs Data Manager should have the skills and qualifications that align with your job description, such as:

• Thorough understanding of regulatory compliance and knowledge of regulatory affairs in the relevant industry.
• Exceptional organizational skills to manage and maintain large volumes of data accurately.
• Data analysis and critical thinking skills for the interpretation and application of regulations and guidelines for data management.
• Excellent attention to detail to ensure compliance with all regulatory standards and accuracy in reporting.
• Effective communication skills to liaise with different departments, regulatory bodies, and stakeholders, clearly conveying complex regulatory information.
• Problem-solving skills to efficiently identify and address any discrepancies, issues, or gaps in regulatory data.
• Technical skills to use various data management software and tools, including database management systems and data analysis tools.
• Ability to work under pressure and meet strict deadlines, managing multiple projects simultaneously.

 

Regulatory Affairs Data Manager Experience Requirements

Entry-level Regulatory Affairs Data Managers may have 1 to 2 years of experience, frequently through an internship or part-time position in regulatory affairs or data management.

This experience could also be gained through roles such as Data Analyst, Clinical Data Coordinator, or Quality Assurance Analyst in a pharmaceutical or biotech company.

Candidates with more than 2 years of experience have typically honed their skills in regulatory data management, understanding how to navigate regulatory guidelines and compliance requirements while managing, analyzing, and interpreting complex datasets.

Those with more than 5 years of experience in regulatory affairs data management are likely to have developed strategic skills, including planning, coordination, and execution of regulatory data management activities.

They may have also gained experience in leading teams, overseeing data management projects, and interfacing with regulatory bodies.

Professionals with over 7 to 10 years of experience may be ready for a senior managerial position, where they would oversee all regulatory affairs data management operations, set strategic direction, and ensure compliance with international regulations and standards.

They may also have substantial experience in preparing and submitting documentation for regulatory approvals and liaising with regulatory authorities.

 

Regulatory Affairs Data Manager Education and Training Requirements

Regulatory Affairs Data Managers typically hold a bachelor’s degree in a related field such as health science, pharmacy, biochemistry, or life sciences.

They require a firm understanding of clinical trials, drug development processes and regulatory requirements across different regions.

Knowledge in data management and statistics is crucial for this role.

Familiarity with data analysis software such as SAS, SQL, Python, and others is often required.

Further, a master’s degree or advanced courses in regulatory affairs, clinical research, or public health can be advantageous.

Certain positions may require Regulatory Affairs Data Managers to have a certification from recognized bodies such as the Regulatory Affairs Professionals Society (RAPS).

Experience in the pharmaceutical, biotechnology, or medical device industry can also be beneficial.

Candidates who continue to pursue further education or certifications demonstrate their commitment to staying abreast of changes in regulatory guidelines and laws, which is essential in this dynamic field.

 

Regulatory Affairs Data Manager Salary Expectations

A Regulatory Affairs Data Manager can expect to earn an average salary of $98,500 (USD) per year.

However, the actual salary can vary depending on factors such as level of experience, educational qualifications, and the location of the job.

Larger firms or those located in metropolitan areas typically offer higher salaries compared to smaller firms or those in less populated regions.

 

Regulatory Affairs Data Manager Job Description FAQs

What skills does a Regulatory Affairs Data Manager need?

Regulatory Affairs Data Managers require an in-depth understanding of regulatory guidelines and standards.

They should possess strong analytical skills to review and interpret data effectively.

Also, excellent communication skills are necessary to liaise between various departments and regulatory authorities.

Attention to detail, organisational skills, and the ability to manage multiple projects simultaneously are also crucial.

 

What is the educational requirement for a Regulatory Affairs Data Manager?

At a minimum, a bachelor’s degree in a related field such as life sciences, chemistry, or pharmacology is usually required.

However, many employers prefer candidates with a master’s degree or higher.

Additionally, certification in regulatory affairs, such as the Regulatory Affairs Certification (RAC), can be advantageous.

 

What should you look for in a Regulatory Affairs Data Manager resume?

Look for a solid educational background in a relevant field and experience in regulatory affairs or a related area.

In addition to academic qualifications, the resume should demonstrate knowledge and experience with regulatory guidelines and data management.

Skills such as problem-solving, project management, and communication are also important to look for.

 

What qualities make a good Regulatory Affairs Data Manager?

A good Regulatory Affairs Data Manager is detail-oriented and can interpret complex data and regulations.

They must be proactive in maintaining up-to-date knowledge on regulatory changes and advancements.

They should also possess strong communication skills for effective liaison between different parties.

Problem-solving skills, resilience, and the ability to work under pressure are also essential qualities in this role.

 

How challenging is it to recruit a Regulatory Affairs Data Manager?

Recruiting a Regulatory Affairs Data Manager can be challenging due to the specific skill set and knowledge required for the role.

This position requires a unique combination of scientific knowledge, understanding of regulatory guidelines, and data management skills.

Therefore, finding candidates with the right balance of these skills and experience can be time-consuming.

 

Conclusion

And there you have it.

Today, we’ve delved into the intricate world of a regulatory affairs data manager.

Intriguing, isn’t it?

It’s not just about managing data.

It’s about shaping the future of regulatory compliance, one dataset at a time.

With our go-to regulatory affairs data manager job description template and real-world examples, you’re ready for your next career leap.

But why hold back?

Explore further with our job description generator. It’s your next step to laser-focused job listings or refining your resume to perfection.

Remember:

Every piece of data contributes to the broader scope of regulatory affairs.

Let’s shape that future. Together.

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