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Regulatory Affairs Associate Jobs in Indiana (NOW HIRING)

micro1 AI

Regulatory Affairs Specialist

Carmel, IN · Remote

$50 - $70/hr

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 ...

micro1 AI

Regulatory Affairs Specialist

Evansville, IN · Remote

$50 - $70/hr

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 ...

micro1 AI

Regulatory Affairs Specialist

Fort Wayne, IN · Remote

$50 - $70/hr

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 ...

micro1 AI

Regulatory Affairs Specialist

Indianapolis, IN · Remote

$50 - $70/hr

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 ...

micro1 AI

Regulatory Affairs Specialist

South Bend, IN · Remote

$50 - $70/hr

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 ...

micro1 AI

Regulatory Affairs Specialist

Fishers, IN · Remote

$50 - $70/hr

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 ...

Zimmer, Inc.

Regulatory Affairs Manager

Warsaw, IN · On-site

... associates, interns, specialists, and project managers Communicates with Regulatory/Governmental ... Serve as the primary Regulatory Affairs liaison for IT-related initiatives, partnering closely with ...

Roche

Regulatory Affairs Manager

Indianapolis, IN

$106K - $197K/yr

At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as ...

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Regulatory Affairs Associate information

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$37

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How much do regulatory affairs associate jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for regulatory affairs associate 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 is a regulatory affairs associate?

A regulatory affairs associate helps medical and pharmaceutical companies navigate regulatory approval processes so that products conform to all local, state, and federal regulations. As a regulatory affairs associate, you work with a team to obtain approval for products, maintain database systems for relevant information, and create reports required by federal or government agencies. You stay abreast of developments in legislation and regulation that may affect your company, and advise others on best practices for product development within a regulated framework.

What are some common challenges regulatory affairs associates face when coordinating with cross-functional teams?

Regulatory Affairs Associates often collaborate closely with departments such as research and development, quality assurance, and marketing. A common challenge is ensuring all stakeholders understand and adhere to regulatory requirements, which may change frequently. Balancing project timelines with the need for accurate and compliant documentation can also be demanding, especially when teams have competing priorities. Effective communication and proactive planning are key to navigating these challenges successfully.

What are the key skills and qualifications needed to thrive as a regulatory affairs associate, and why are they important?

To thrive as a Regulatory Affairs Associate, you need a solid background in life sciences or related fields, attention to detail, and knowledge of regulatory guidelines and standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong organizational skills, effective communication, and the ability to work collaboratively are important soft skills in this role. These abilities ensure accurate documentation, timely regulatory submissions, and successful navigation of complex compliance requirements.
More about Regulatory Affairs Associate jobs
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What cities in Indiana are hiring for Regulatory Affairs Associate jobs? Cities in Indiana with the most Regulatory Affairs Associate job openings:
Regulatory Affairs Associate jobs near you
Infographic showing various Regulatory Affairs Associate job openings in Indiana as of July 2026, with employment types broken down into 83% Full Time, and 17% Contract. Highlights an 83% In-person, and 17% Remote job distribution, with an average salary of $78,320 per year, or $37.7 per hour.

Regulatory Affairs Specialist

micro1 AI

Carmel, IN • Remote

$50 - $70/hr

Part-time

Posted 5 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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