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Regulatory Writing Jobs in Indiana (NOW HIRING)

micro1 AI

Regulatory Affairs Specialist

Evansville, 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

Regulatory Affairs Specialist

Fort Wayne, 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

Regulatory Affairs Specialist

Carmel, 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

Regulatory Affairs Specialist

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 ...

micro1 AI

Medical Billing Specialist

Carmel, IN · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Regulatory Affairs Specialist

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

Regulatory Affairs Specialist

Indianapolis, 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 ...

Zimmer, Inc.

Regulatory Affairs Manager

Warsaw, IN

Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports * Strong ...

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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:
What job categories do people searching Regulatory Writing jobs in Indiana look for? The top searched job categories for Regulatory Writing jobs in Indiana are:
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 Affairs Specialist

micro1 AI

Evansville, IN • Remote

$50 - $70/hr

Part-time

Posted 4 days ago

Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

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