ZipRecruiter

Log In

1

Regulatory Writing Jobs in Indiana (NOW HIRING)

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 ...

Zimmer, Inc.

Regulatory Affairs Manager

Warsaw, IN · On-site

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

IQVIA

Regulatory Affairs Director

Indianapolis, IN · On-site

$128K - $358K/yr

Viewed as a leading expert within the field by peers Extensive experience in regulatory and/or technical writing Advanced negotiating and influencing skills and the ability to identify and resolve ...

IQVIA

Regulatory Affairs Director

Indianapolis, IN

$128K - $358K/yr

Viewed as a leading expert within the field by peers Extensive experience in regulatory and/or technical writing Advanced negotiating and influencing skills and the ability to identify and resolve ...

next page

Showing results 1-20

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 Jul 18, 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 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.

How much do regulatory writers make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in areas like pharmaceuticals or medical devices can earn higher salaries, often exceeding $130,000. Strong writing skills, industry certifications, and familiarity with regulatory guidelines are important for higher compensation.

What do regulatory writers do?

Regulatory writers create and prepare documentation required for product approvals, such as clinical trial reports, regulatory submissions, and safety reports. They ensure these documents comply with industry standards and regulatory agency guidelines, often using specialized tools and maintaining accuracy under strict deadlines.

What are the key skills and qualifications needed to thrive in the Regulatory Writing position, and why are they important?

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.

Are medical writers going to be replaced by AI?

Medical writers, including those in regulatory writing, are unlikely to be fully replaced by AI, as their role requires critical thinking, interpretation of complex data, and adherence to regulatory standards. AI tools can assist with drafting and editing, but human expertise remains essential for ensuring accuracy, compliance, and clarity in regulatory documents.

What is the highest paying writing job?

In the field of regulatory writing, senior roles such as Regulatory Affairs Director or Vice President often have the highest salaries, especially in the pharmaceutical and biotech industries. These positions typically require extensive experience, specialized knowledge of regulations, and leadership skills, with salaries reaching six figures or more depending on the company and location.

What is a Regulatory Writing job?

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 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
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Intellectt INC

Indianapolis, IN • On-site

Contractor

Posted 22 days ago

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.