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Regulatory Writing Jobs in Indiana (NOW HIRING)

micro1 AI

Medical Writing Manager

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

Medical Writing Manager

Evansville, 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

Medical Writing Manager

Fishers, 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

Medical Writing Manager

Indianapolis, 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

Medical Writing Manager

Fort Wayne, 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

Medical Writing Manager

South Bend, 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 ...

MMS

Senior Medical Writer (Remote)

Zionsville, IN · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with client templates & style guides * Interact directly and independently with client to coordinate all ...

micro1 AI

Medical Billing Specialist

Evansville, 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

Medical Billing Specialist

Indianapolis, 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

Medical Billing Specialist

Fishers, 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

Medical Billing Specialist

South Bend, 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

Medical Billing Specialist

Fort Wayne, 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 ...

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All JobsRegulatory Writing JobsRegulatory Writing Jobs in Indiana

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

Intellectt INC

Indianapolis, IN • On-site

Contractor

This job post has expired today. Applications are no longer accepted.

Job description

Job Title: Regulatory Affairs Specialist
Location: Indiana, USA
Duration: Long-term

Job Summary

The Regulatory Affairs Specialist will support regulatory compliance activities for pharmaceutical manufacturing operations. The role is responsible for preparing, reviewing, and maintaining regulatory documentation, supporting FDA submissions, ensuring cGMP compliance, coordinating with Quality, Manufacturing, Validation, Packaging, and Supply Chain teams, and helping maintain product compliance throughout the manufacturing lifecycle.

Key Responsibilities

  • Prepare, review, and maintain regulatory documents for pharmaceutical products and manufacturing changes.
  • Support FDA submissions, amendments, annual reports, supplements, and regulatory correspondence.
  • Ensure manufacturing, packaging, labeling, and documentation activities comply with FDA and cGMP requirements.
  • Review change controls related to process, equipment, facility, raw materials, packaging, and labeling.
  • Coordinate with QA, QC, Manufacturing, Validation, Engineering, and Supply Chain teams for regulatory impact assessments.
  • Support review of batch records, SOPs, validation documents, specifications, and technical reports from a regulatory perspective.
  • Maintain regulatory files, product dossiers, licenses, approvals, and submission trackers.
  • Assist in preparing responses to FDA queries, deficiency letters, and inspection observations.
  • Monitor updates in FDA regulations, guidance documents, and internal compliance requirements.
  • Support internal audits, regulatory inspections, and inspection readiness activities.
  • Ensure timely documentation and escalation of regulatory risks or compliance gaps.
  • Maintain accurate records in accordance with company SOPs and regulatory standards.

Skills Required

  • Strong understanding of FDA regulations, cGMP, and pharmaceutical manufacturing compliance.
  • Knowledge of regulatory submissions, lifecycle management, labeling, and change control.
  • Familiarity with NDA, ANDA, IND, DMF, supplements, annual reports, or CMC documentation.
  • Ability to review SOPs, batch records, validation reports, and technical documents.
  • Strong documentation, analytical, and regulatory writing skills.
  • Good knowledge of quality systems, deviation, CAPA, and change management processes.
  • Excellent communication and cross-functional coordination skills.
  • Strong attention to detail and ability to work in a regulated environment.
  • Proficiency in MS Office and regulatory document management systems.
  • Ability to manage deadlines, priorities, and multiple regulatory activities.

Preferred Qualifications

  • Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or related field.
  • 1–5 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing Compliance, or CMC Regulatory Affairs.
  • Experience in U.S. pharmaceutical manufacturing or FDA-regulated environments preferred.