Gastroenterology Regulatory Affairs Specialist Job Description [Updated for 2025]

In the rapidly evolving healthcare landscape, the role of Gastroenterology Regulatory Affairs Specialists has become increasingly critical.

As medical innovations continue to unfold, the need for skilled professionals who can navigate, enhance, and protect our gastroenterological regulatory procedures is growing significantly.

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

Whether you are:

• A job seeker aiming to understand the nuances of this role,
• A hiring manager defining the perfect candidate,
• Or simply fascinated by the intricacies of gastroenterological regulatory affairs,

You’ve come to the right place.

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

Let’s dive right in.

Gastroenterology Regulatory Affairs Specialist Duties and Responsibilities

Gastroenterology Regulatory Affairs Specialists perform a range of tasks related to the development, registration, and post-approval activities of gastroenterology products.

They work closely with various internal departments as well as external regulatory agencies to ensure all products meet the necessary regulations and standards.

The duties and responsibilities of a Gastroenterology Regulatory Affairs Specialist include:

• Reviewing and approving labeling, packaging, and promotional materials to ensure regulatory compliance
• Interpreting regulatory rules and regulations and providing guidance to staff and management
• Preparing and submitting documentation for regulatory agencies, such as the Food and Drug Administration (FDA) or European Medicines Agency (EMA)
• Leading and managing regulatory inspections and audits
• Developing and implementing regulatory strategies for new and modified products
• Maintaining current knowledge of all relevant regulatory requirements related to gastroenterology products
• Ensuring compliance with regulations and maintaining all necessary documentation
• Collaborating with other teams to ensure clinical trials are conducted in accordance to regulatory requirements
• Participating in product development teams to provide regulatory guidance and planning
• Assessing the impact of changes in regulations on existing and new products

 

Gastroenterology Regulatory Affairs Specialist Job Description Template

Job Brief

We are looking for a detail-oriented Gastroenterology Regulatory Affairs Specialist to join our team.

The successful candidate will be responsible for ensuring our company complies with all regulations and laws pertaining to gastroenterology products.

This includes preparing submissions for regulatory agencies, managing regulatory files, and coordinating with various departments to ensure compliance.

Our ideal candidate has a background in life sciences and a deep understanding of gastroenterology products and their associated regulatory requirements.

The ability to stay updated with evolving regulatory norms and the ability to communicate effectively are key to this position.

 

Responsibilities

• Prepare and submit regulatory documents related to gastroenterology products
• Maintain regulatory files and track changes to regulatory guidelines
• Coordinate with various departments to ensure compliance with all regulations and guidelines
• Participate in regulatory inspections and audits
• Keep up-to-date with international legislation, guidelines, and customer practices
• Develop and implement regulatory strategies for new products
• Provide regulatory advice and guidance to project teams
• Support new product development and changes to existing products

 

Qualifications

• Proven experience as a Regulatory Affairs Specialist or similar role
• Strong knowledge of federal and international regulatory requirements
• Experience preparing regulatory submissions
• Strong communication and negotiation skills
• Attention to detail and strong organizational skills
• Ability to interpret and apply complex regulations and guidelines
• BSc/BA in life sciences or related field
• Professional certification in Regulatory Affairs is a plus

 

Benefits

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

 

Additional Information

• Job Title: Gastroenterology Regulatory Affairs Specialist
• Work Environment: This is an office-based role, with occasional travel for regulatory meetings or industry conferences.
• 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: $70,000 minimum to $120,000 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 Gastroenterology Regulatory Affairs Specialist Do?

Gastroenterology Regulatory Affairs Specialists primarily work in the pharmaceutical, biotechnology, or medical device industry.

They play a crucial role in ensuring that the company’s products comply with all the regulations and laws pertaining to the healthcare sector.

They are responsible for the preparation, coordination, and compiling of regulatory submissions for new or existing products, such as applications for clinical trials or marketing authorizations.

They work closely with various departments including research and development, manufacturing, and quality assurance to ensure that all documents meet regulatory standards.

The Gastroenterology Regulatory Affairs Specialist also keeps track of changing regulations in all the geographical areas where the company’s products are marketed.

They advise the company of any changes to regulations and how they could impact the company’s operations.

They may also be involved in the development and implementation of regulatory strategy, and in the coordination of internal audits.

Moreover, they communicate with regulatory authorities, answer their queries, and ensure that the company’s responses and corrective actions are timely and appropriate.

Ensuring patient safety is also an important aspect of their role, as they are responsible for the reporting of any adverse events or product complaints.

Lastly, Gastroenterology Regulatory Affairs Specialists play a key role in product development, advising teams on regulatory requirements for new products or changes to existing products.

 

Gastroenterology Regulatory Affairs Specialist Qualifications and Skills

A Gastroenterology Regulatory Affairs Specialist should have the skills and qualifications that align with the role and responsibilities of the job, such as:

• Knowledge of medical procedures, medical terminology and pathophysiology related to gastroenterology to effectively manage related regulatory affairs.
• Expertise in the development and implementation of regulatory strategies for products related to gastroenterology.
• Understanding of regulatory affairs in healthcare, particularly in the field of gastroenterology, including knowledge of FDA, EMA and other global health authority regulations.
• Strong analytical skills to understand complex regulatory requirements and translate them into practical implementation plans.
• Exceptional attention to detail to ensure that all documentation and reporting complies with regulatory standards.
• Excellent written and verbal communication skills to effectively interact with regulatory authorities and other stakeholders.
• Ability to multitask and manage multiple projects under tight deadlines.
• Strong organizational skills for managing and maintaining all regulatory documentation in a structured and systematic manner.
• Problem-solving skills to address any issues that arise during the regulatory process and find effective solutions.

 

Gastroenterology Regulatory Affairs Specialist Experience Requirements

Gastroenterology Regulatory Affairs Specialists are generally required to have at least 3 to 5 years of experience in regulatory affairs within the field of gastroenterology or a related healthcare field.

Entry-level candidates may gain their initial experience through internships or part-time roles in the healthcare industry, with a focus on regulatory affairs, compliance, or quality assurance.

They may also gain experience in roles such as a Clinical Research Associate, Regulatory Affairs Assistant, or Quality Assurance Specialist.

Candidates with 3 to 5 years of experience often have developed their knowledge of regulatory procedures and guidelines, including FDA regulations and ISO standards, in previous roles.

They may also have experience with product submissions, regulatory audits, and compliance inspections.

Those with more than 5 years of experience may have advanced knowledge of global regulatory affairs, and may be ready for leadership roles within the organization.

This level of experience may also include direct involvement in the development and implementation of regulatory strategies, as well as the management of regulatory submissions and communications with regulatory agencies.

All Gastroenterology Regulatory Affairs Specialists should ideally have experience in communicating and collaborating with various levels of management, and should have a strong understanding of the technical aspects of gastroenterology, including the devices and treatments used in this medical specialty.

 

Gastroenterology Regulatory Affairs Specialist Education and Training Requirements

Gastroenterology Regulatory Affairs Specialists typically need a bachelor’s degree in life sciences, pharmacy, or a related field.

A strong foundation in biology, chemistry, physiology and other related disciplines is essential.

Familiarity with regulatory frameworks and protocols related to the gastroenterology field is a must.

In addition to the bachelor’s degree, most employers require a minimum of 2-5 years of experience in regulatory affairs, preferably in the healthcare or pharmaceutical industries.

A master’s degree or PhD in a related field, such as regulatory science, healthcare administration, or public health, can enhance job prospects and advancement opportunities.

Such advanced degrees provide in-depth knowledge about regulations, policy-making, and compliance, which are pivotal to the role.

Certifications such as Regulatory Affairs Certification (RAC) or Certified Regulatory Affairs Professional (CRAP) can further boost credibility and demonstrate commitment to staying updated in the field.

Having experience with clinical trials, product development, and submission of regulatory documents is also beneficial.

Continual professional development is important in this role due to the constant changes in healthcare regulations and standards.

 

Gastroenterology Regulatory Affairs Specialist Salary Expectations

A Gastroenterology Regulatory Affairs Specialist earns an average salary of $84,000 (USD) per year.

However, this figure may fluctuate based on factors such as years of experience in the field, specific qualifications, geographical location, and the size and type of the employing organization.

 

Gastroenterology Regulatory Affairs Specialist Job Description FAQs

What skills does a Gastroenterology Regulatory Affairs Specialist need?

This specialist should have a deep understanding of regulatory guidelines and standards related to gastroenterology.

They should be able to analyze and interpret clinical data, possess excellent written and oral communication skills, and have a keen eye for detail.

They should also be organized and able to manage multiple projects at once, as well as have the ability to collaborate effectively with various stakeholders, including clinicians, researchers, and regulatory bodies.

 

Do Gastroenterology Regulatory Affairs Specialists need a degree?

Yes, a minimum of a bachelor’s degree in life sciences, health sciences, or a related field is usually required.

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

Some roles may also require specific certification in regulatory affairs.

In addition, substantial experience in regulatory affairs, preferably within the field of gastroenterology, is often required.

 

What should you look for in a Gastroenterology Regulatory Affairs Specialist resume?

Look for a strong background in regulatory affairs, particularly within the pharmaceutical or healthcare sector.

Experience with the Food and Drug Administration (FDA) and European Medicines Agency (EMA) procedures is a plus.

Also, any experience in clinical research or drug development within the field of gastroenterology can be beneficial.

Finally, any certifications in regulatory affairs should also be highlighted.

 

What qualities make a good Gastroenterology Regulatory Affairs Specialist?

A good Gastroenterology Regulatory Affairs Specialist should be detail-oriented, as this role involves interpreting and ensuring compliance with complex regulatory requirements.

They should be proactive, able to anticipate potential regulatory issues and devise strategies to mitigate these risks.

They should also have strong problem-solving skills and the ability to work effectively under pressure.

 

Is it difficult to hire a Gastroenterology Regulatory Affairs Specialist?

The hiring process can be challenging due to the specialized knowledge required for this role.

It’s important to find a candidate who not only has the necessary regulatory affairs experience, but also a deep understanding of gastroenterology.

Consequently, you may need to conduct an extensive search, possibly involving recruitment agencies that specialize in healthcare and life sciences.

However, with the right approach, you can find a specialist who will be an invaluable asset to your organization.

 

Conclusion

So, there you go.

Today, we’ve unveiled the in-depth reality of being a Gastroenterology Regulatory Affairs Specialist.

What’s the catch?

It’s not solely about managing regulations.

It’s about shaping the future of gastroenterology, one regulation at a time.

With our handy Gastroenterology Regulatory Affairs Specialist job description template and real-world examples, you’re equipped to take the leap.

But don’t stop here.

Venture further with our job description generator. It’s your next step to create precise job listings or refining your resume to perfection.

Remember:

Each regulation is a piece of a larger puzzle.

Let’s shape that future. Together.

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