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Regulatory Writing Jobs in Indiana (NOW HIRING)

Ivy Tech

Part-Time ESOL Writing Tutor

Indianapolis, IN · On-site

$18/hr

... regulatory requirements, and professional standards. * Use established Writing Center pedagogy and ... protocols to tutor students one-on-one at various points of the writing process, working on written ...

Ivy Tech

Part-Time ESOL Writing Tutor

Indianapolis, IN · On-site

$18/hr

... regulatory requirements, and professional standards. * Use established Writing Center pedagogy and ... protocols to tutor students one-on-one at various points of the writing process, working on written ...

Intellectt INC

Deviation Writer

Indianapolis, IN · On-site

... writing experience in a GMP-regulated environment (pharmaceutical, biopharmaceutical, or biotechnology preferred). * Strong understanding of GMP manufacturing processes and regulatory requirements.

micro1 AI

Compliance Officers

South Bend, IN · Remote

$50 - $70/hr

Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions. * Collaborate asynchronously and communicate complex regulatory ...

micro1 AI

Compliance Officers

Fishers, IN · Remote

$50 - $70/hr

Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions. * Collaborate asynchronously and communicate complex regulatory ...

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Regulatory Writing information

See Indiana salary details

$14

$32

$138

How much do regulatory writing jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for regulatory writing in Indiana is $32.92, according to ZipRecruiter salary data. Most workers in this role earn between $21.25 and $24.95 per hour, depending on experience, location, and employer.

What is an example of regulatory writing?

Regulatory writing involves creating documents such as clinical study reports, regulatory submission dossiers, or standard operating procedures that comply with industry standards and guidelines. These documents are used to support product approvals and require precise, clear, and compliant language, often utilizing tools like document management systems and adhering to regulations from agencies like the FDA or EMA.

What are some common challenges faced by regulatory writers in the industry?

Regulatory Writers often face tight deadlines and the need to manage complex, highly detailed documents that must comply with evolving regulatory requirements. They regularly coordinate input from diverse teams such as clinical, safety, and regulatory affairs, which can pose communication and alignment challenges. Staying current with changing international regulations and ensuring absolute accuracy in submissions are other common demands. However, these challenges also make the work engaging and offer opportunities to continuously learn and develop expertise in both scientific communication and regulatory affairs.

What are the key skills and qualifications needed to thrive in regulatory writing?

To thrive in Regulatory Writing, you need expertise in scientific or medical writing, an understanding of regulatory guidelines (such as FDA, EMA, or ICH), and typically a background in life sciences or related fields. Competence with document management systems, referencing tools like EndNote, and familiarity with submission platforms are often required. Strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams are key soft skills. These skills ensure the creation of accurate, compliant, and clear regulatory documents critical for drug and device approval processes.

What is regulatory writing?

A Regulatory Writing job involves creating and reviewing documents required for regulatory submissions in industries like pharmaceuticals, biotechnology, and medical devices. Regulatory writers ensure that documents comply with guidelines from regulatory agencies such as the FDA or EMA. Their work includes clinical study reports, investigator brochures, and regulatory submission dossiers. Strong writing skills, scientific knowledge, and attention to detail are essential for this role.

What does a regulatory writing do?

A regulatory writer creates and edits documents required for regulatory submissions to agencies such as the FDA or EMA, ensuring compliance with industry standards. They often work with technical data, use specialized tools, and have knowledge of regulatory guidelines to prepare clear, accurate, and complete documentation for product approval processes.
What are the most commonly searched types of Regulatory Writing jobs in Indiana? The most popular types of Regulatory Writing jobs in Indiana are:
What are popular job titles related to Regulatory Writing jobs in Indiana? For Regulatory Writing jobs in Indiana, the most frequently searched job titles are:
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What cities in Indiana are hiring for Regulatory Writing jobs? Cities in Indiana with the most Regulatory Writing job openings:
Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in Indiana as of August 2026, with employment types broken down into 79% Full Time, 9% Part Time, 4% Temporary, and 8% Contract. Highlights an 92% In-person, and 8% Remote job distribution, with an average salary of $68,475 per year, or $32.9 per hour.

Regulatory Coordinator | On-site, Indianapolis, IN

Intersurgical, Inc

Indianapolis, IN • On-site

$60K - $70K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 2 days ago

New

Job description

About Us

Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care, and medical device manufacturing. We partner with providers, manufacturers, and other organizations to supply innovative airway and medical devices that impact the lives of patients every day.

Driven by our commitment to supply high-quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.

Our Culture

We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic self.

We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view.

Job Overview:

Primary responsibility is assisting with regulatory activities pertaining to distribution of products in the US market.

Assist with generating and maintaining documentation required to allow products to be marketed domestically as well as to assist with maintaining compliance with QMS regulations.

Responsibilities:

  • Assist with Maintaining Complaint Documentation and Related Activities
  • Maintain Documentation for Internal & External Audits
  • Providing SOP Training and maintaining training matrix
  • Assist with Regulatory Affairs Manager with Regulatory Activities

Education/Experience:

  • Bachelor’s degree in quality, risk management or related field.
  • Must be able to speak, read and write English.
  • Understanding and experience with US FDA, and ISO Regulatory requirements.
  • Ability to work independently and cope with changing priorities, and to prioritize workload to meet datelines.
  • 3+ years of experience preferred.

Skills & Competencies:

  • Key skills needed: Work independently, work and maintain priority in a timely manner.
  • Technical or software proficiencies required: Competency in MSWord, Adobe Acrobat and Excel

Physical & Work Environment Requirements:

Must be able to sit, stand and/or walk for extended periods of time. Must be able to lift 25 lbs.

Work conditions: Office Setting

Benefits:

We are passionate about the well-being of others and that begins with caring for our people.

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????Multiple opportunities to be challenged and step up your career in a fast-growth company

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????️Paid Time Off and holidays

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