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Regulatory Writing Jobs in Indiana (NOW HIRING)

Aequor

... regulations Writes and manages the development of package inserts Reviews and evaluations promotion and advertising material for compliance with applicable regulations Reviews proposed product ...

New

Aequor

Regulatory Affairs Specialist

Warsaw, IN · On-site

Writes and manages the development of package inserts * Reviews and evaluations promotion and advertising material for compliance with applicable regulations * Reviews proposed product changes for ...

New

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $52/hr

Writes and manages the development of package inserts * Reviews and evaluations promotion and advertising material for compliance with applicable regulations * Reviews proposed product changes for ...

New

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 ...

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$48 - $52/hr

Writes and manages the development of package inserts * Reviews and evaluations promotion and advertising material for compliance with applicable regulations * Reviews proposed product changes for ...

New

Actalent

Regulatory Affairs Specialist

Warsaw, IN

$50 - $55/hr

Regulatory Affairs Specialist The Regulatory Affairs Specialist assists the regulatory team with ... Write and manage the development, review, and maintenance of package inserts for medical devices.

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Jj

Manager, Technical Regulatory Compliance

Warsaw, IN · On-site

Effective written and verbal communication skills. Preferred: * Experience in medical devices, healthcare, or other highly regulated industries. * Familiarity with U.S. regulatory and technical ...

Synkriom

Be Seen First

Medical Device Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $55/hr

Strong writing, communication, and interpersonal skills * Strong attention to detail; ability to ... Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and ...

New

Roche

Regulatory Affairs Project Manager

Indianapolis, IN · On-site

$84K - $157K/yr

As a Regulatory Affairs Project Manager you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health ...

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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 28, 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 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 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 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 does a regulatory writing make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, location, and industry sector. Senior roles or those with specialized knowledge in areas like pharmaceuticals or biotech can command higher salaries, often supplemented by benefits and bonuses.

What does a regulatory writing do?

A regulatory writer creates and prepares documentation required for the approval of medical, pharmaceutical, or biotech products by regulatory agencies. They ensure that submissions such as clinical trial reports, safety updates, and product dossiers comply with industry standards and regulations, often using specialized tools and adhering to strict deadlines.

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 regulatory agency requirements. These documents are essential for obtaining approvals from agencies like the FDA or EMA and require precise, clear, and well-organized language. Regulatory writers often use specialized tools and adhere to strict formatting guidelines to ensure accuracy and consistency.

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 85% Full Time, 9% Part Time, 4% Temporary, and 2% Contract. Highlights an 93% In-person, 3% Hybrid, and 4% Remote job distribution, with an average salary of $68,475 per year, or $32.9 per hour.

Regulatory Affairs Specialist

Aequor

On-site

Full-time

Posted 2 days ago

New

Job description

Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties Responsible for assisting the team with regulatory filings as necessary to market our client's products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process. Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions. Respond to requests from foreign government and/or distributors as needed Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products Evaluate risk of proposed regulatory strategies; may offer solutions Reviews proposed labeling for compliance with applicable global regulations Writes and manages the development of package inserts Reviews and evaluations promotion and advertising material for compliance with applicable regulations Reviews proposed product changes for impact on regulatory status of the product Communicates with regulatory and governmental agencies with supervision Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams Skills Strong writing, communication, and interpersonal skills Strong attention to detail; ability to multi-task and balance competing priorities Knowledge of overall business environment, the orthopaedic industry, and the marketplace Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels Knowledge of FDA, EU, and other regulatory body regulations Ability to identify risk in Regulatory strategies Strong problem solving skills Effective negotiating skills Basic computer skills, including Microsoft Office Suite Education Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred A minimum of one year of experience in orthopaedic or medical device industry preferred A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required Regulatory Affairs Certification (US or EU) preferred A combination of education and experience may be considered #TechAM Salary: . Date posted: 08/26/2026

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