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Fda Regulatory Jobs in Indiana (NOW HIRING)

BioTalent

Ensure compliance with study protocols, ICH-GCP , FDA regulations, and applicable SOPs. * Perform source data verification, resolve site queries, and maintain data integrity and quality. * Manage ...

Harlan Bakeries LLC

Compliance Coordinator II

Avon, IN · On-site

Overview The Compliance Coordinator II is responsible for document compliance with FDA regulations and company standards as well as providing staff support related to documentation and records. Job ...

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How much do fda regulatory jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for fda regulatory 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 an FDA Regulatory?

An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.

What are the main responsibilities of an FDA Regulatory?

Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.

What are the key skills and qualifications needed to thrive in an FDA Regulatory position?

To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.

How can I get into FDA regulatory?

To enter FDA regulatory roles, candidates typically need a background in life sciences, healthcare, or engineering, along with knowledge of FDA regulations and compliance processes. Relevant experience can be gained through internships, certifications such as RAC (Regulatory Affairs Certification), or working in quality assurance or compliance departments. Strong analytical skills, attention to detail, and understanding of medical device or pharmaceutical development are also important.

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

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

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

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

Fda Regulatory jobs near you
Infographic showing various Fda Regulatory job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 11% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $78,320 per year, or $37.7 per hour.

Senior Clinical Research Associate

BioTalent

On-site

Other

Posted 5 days ago

Job description


We are seeking an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites throughout the full study lifecycle, from start-up through close-out. This is a highly autonomous, field-based role requiring an experienced monitor who can take ownership of site activities with minimal supervision while ensuring the highest standards of compliance, data quality, and site performance.


Key Responsibilities

Independently conduct:

  • Site Qualification Visits (SQVs)
  • Site Initiation Visits (SIVs)
  • Interim Monitoring Visits (IMVs)
  • Close-Out Visits (COVs)
  • Serve as the primary point of contact for assigned clinical trial sites.
  • Ensure compliance with study protocols, ICH-GCP, FDA regulations, and applicable SOPs.
  • Perform source data verification, resolve site queries, and maintain data integrity and quality.
  • Manage Investigator Site Files (ISF) and support Trial Master File (TMF) documentation to maintain inspection readiness.
  • Conduct investigational product accountability and reconciliation activities.
  • Provide ongoing site training, support, and guidance throughout the study lifecycle.
  • Complete monitoring reports, follow-up letters, and visit documentation within required timelines.
  • Identify, escalate, and support resolution of site issues and compliance risks.


Requirements

  • Bachelor's degree in Life Sciences or a related scientific discipline.
  • Minimum 5 years of CRA monitoring experience within clinical research.
  • Proven experience independently managing sites across the full clinical trial lifecycle.
  • Strong knowledge of:
  • ICH-GCP
  • FDA regulations
  • Clinical trial operations
  • eCRF and electronic data capture systems
  • Demonstrated ability to manage multiple sites and priorities simultaneously.


Contract Details

  • Valid driver's licence required.
  • Up to 100% travel required, including air and ground travel.

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