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Regulatory Publisher Jobs in Indiana (NOW HIRING)

Merck & Co.

Regulatory Affairs Specialist

Warsaw, IN · On-site

Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties * Assist with ... May author and publish electronic submissions. * Respond to requests from foreign government and/or ...

Aequor

Regulatory Affairs Specialist

Warsaw, IN · On-site

Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties Responsible for ... May author and publish electronic submissions. * Respond to requests from foreign government and/or ...

Aequor

May author and publish electronic submissions. Respond to requests from foreign government and/or ... regulatory pathway for new or modified products Provides regulatory direction to development ...

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $52/hr

Regulatory Affairs Specialist Location: Warsaw, IN 46580 (100% onsite) Duration: 12+ Months ... May author and publish electronic submissions. * Respond to requests from foreign government and/or ...

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$48 - $52/hr

Regulatory Affairs Specialist Location: Warsaw, IN 46580 (100% onsite) Duration: 12+ Months ... May author and publish electronic submissions. * Respond to requests from foreign government and/or ...

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$45 - $52/hr

Regulatory Affairs Specialist Location: Warsaw, IN 46580 (100% onsite) Duration: 12+ Months ... May author and publish electronic submissions. * Respond to requests from foreign government and/or ...

Mesa Air Group

CASS Analyst

Carmel, IN

Responsible for accurate, efficient collection, analysis and entry of data and publishing of the ... Submits data reports to OEM and other entities and regulatory agencies under the direction of the ...

Steuben County

Assistant Plan Director

Steuben, IN · On-site

Publishes and provides notice of public hearings and meetings according to state and local requirements. Cooperates with regulating agencies in administering flood plain management program, including ...

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Regulatory Publisher information

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How much do regulatory publisher jobs pay per hour?

As of Sep 15, 2026, the average hourly pay for regulatory publisher in Indiana is $37.65, according to ZipRecruiter salary data. Most workers in this role earn between $30.19 and $44.62 per hour, depending on experience, location, and employer.

What does a regulatory publisher do?

A Regulatory Publisher is responsible for compiling, formatting, and submitting regulatory documents to health authorities, ensuring compliance with global submission standards such as eCTD (Electronic Common Technical Document). They work closely with regulatory affairs teams to prepare dossiers for drug approvals, variations, and renewals. Their role involves quality control, document troubleshooting, and staying up to date with regulatory submission requirements. Effective use of publishing software and strict adherence to guidelines are essential for ensuring successful submissions.

What are the key skills and qualifications needed to thrive as a regulatory publisher?

To thrive as a Regulatory Publisher, you need a thorough understanding of regulatory submission requirements, document management, and attention to detail, typically supported by experience in the pharmaceutical or biotechnology industries. Proficiency with electronic submission tools such as eCTD publishing software (e.g., Lorenz DocuBridge, Extedo), and familiarity with FDA or EMA guidelines, are highly valued. Strong organization, effective communication, and the ability to manage multiple projects simultaneously are important soft skills. These abilities are vital for ensuring timely, compliant submissions and efficient collaboration across regulatory and project teams.

What are some typical challenges a regulatory publisher might face in their daily work?

Regulatory Publishers often encounter tight deadlines and frequently changing regulatory requirements, which can make prioritizing tasks and staying up-to-date a challenge. Managing complex submissions that involve compiling, formatting, and validating large volumes of documentation requires both technical and organizational expertise. Additionally, close collaboration with regulatory affairs, medical writers, and quality assurance teams is essential to ensure submissions are accurate and compliant. Overcoming these challenges involves a keen attention to detail, adaptability, and strong communication skills, all of which are highly valued in this role.

What are popular job titles related to Regulatory Publisher jobs in Indiana?

For Regulatory Publisher jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Regulatory Publisher jobs in Indiana look for?

The top searched job categories for Regulatory Publisher jobs in Indiana are:

Regulatory Publisher jobs near you
Infographic showing various Regulatory Publisher job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $78,320 per year, or $37.7 per hour.

Regulatory Affairs Specialist

Warsaw, IN • On-site

Merck & Co.
Pharmaceutical Product Wholesalers • 10K+ employees
Learn more about Merck & Co.external

Other

Posted 12 days ago

Merck rating

7.9

Company rating: 7.9 out of 10

Based on 52 frontline employees who took The Breakroom Quiz

Job description

Regulatory Affairs Specialist
1 Year Contract
Warsaw, IN (100% Onsite) Duties
  • 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
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