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Fda Regulatory Jobs in Indiana (NOW HIRING)

E Solutions

GMP Engineer

Indianapolis, IN · On-site

Regulatory & Quality Assurance * Maintain knowledge of industry regulations including FDA, GMP, and GAMP guidelines. * Develop and maintain validation procedures aligned with regulatory requirements.

E Solutions

GMP Engineer

Indianapolis, IN · On-site

Regulatory & Quality Assurance * Maintain knowledge of industry regulations including FDA, GMP, and GAMP guidelines. * Develop and maintain validation procedures aligned with regulatory requirements.

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$37

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How much do fda regulatory jobs pay per hour?

As of Aug 8, 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 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.

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.

How can I get into FDA regulatory?

To pursue a career in FDA regulatory roles, candidates typically need a background in life sciences, healthcare, or regulatory affairs, along with knowledge of FDA regulations and compliance processes. Gaining relevant experience through internships, certifications such as RAC (Regulatory Affairs Certification), and understanding of medical device or pharmaceutical development can improve job prospects. Strong communication skills and familiarity with regulatory submission tools are also beneficial.
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 July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $78,320 per year, or $37.7 per hour.

Regulatory Affairs Specialist

Intellectt INC

Indianapolis, IN • On-site

Contractor

This job post has expired today. Applications are no longer accepted.

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.