Regulatory Affairs Analyst Jobs in Indiana
Regulatory affairs analyst jobs in Indiana are concentrated in Indianapolis, the Midwest's most active hub for life sciences and pharmaceutical compliance, with additional demand in Columbus and South Bend. Eli Lilly, Zimmer Biomet, and Cook Medical are among the established Indiana employers that consistently hire regulatory affairs analysts across device submissions, pharmaceutical compliance, and FDA regulatory strategy. Openings range from entry-level associates supporting submission pipelines to senior analysts owning 510(k) and PMA filings independently. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 14+ Regulatory Affairs Analyst jobs
Job Overview
Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.
- May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations
- Undertakes risk analysis, management and contingency plans
- Must ensure that regulatory colleagues on the project have the tools and training needed to undertake the various tasks
- Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results
- Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans
- Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA
- May take leadership role in bid defense strategy and planning
- May act as global regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
- May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience
- Responsible for making major improvements to processes and systems across functions or large departments
- Problems faced are highly complex and require solutions drawn from best practices and expertise, as well as from extensive analysis into the root cause
- Bachelor's Degree Lifescience or related discipline Required
- At least 10 years relevant experience including 8 years regulatory experience
- Requires extensive knowledge of multiple job areas obtained through advanced education and experience; Viewed as a leading expert within the field by peers
- Extensive experience in regulatory and/or technical writing
- Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach
- Remains calm, assertive and diplomatic in challenging interactions with customers
- Strong software and computer skills, including Microsoft Office applications
- Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues
- Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
- Ability to exercise independent judgement taking calculated risks when making decisions
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.Job Overview
Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.
- May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations
- Undertakes risk analysis, management and contingency plans
- Must ensure that regulatory colleagues on the project have the tools and training needed to undertake the various tasks
- Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results
- Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans
- Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA
- May take leadership role in bid defense strategy and planning
- May act as global regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
- May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience
- Responsible for making major improvements to processes and systems across functions or large departments
- Problems faced are highly complex and require solutions drawn from best practices and expertise, as well as from extensive analysis into the root cause
- Bachelor's Degree Lifescience or related discipline Required
- At least 10 years relevant experience including 8 years regulatory experience
- Requires extensive knowledge of multiple job areas obtained through advanced education and experience; Viewed as a leading expert within the field by peers
- Extensive experience in regulatory and/or technical writing
- Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach
- Remains calm, assertive and diplomatic in challenging interactions with customers
- Strong software and computer skills, including Microsoft Office applications
- Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues
- Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
- Ability to exercise independent judgement taking calculated risks when making decisions
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.See All 14 Regulatory Affairs Analyst Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Analyst Jobs by City in Indiana
Where Indiana roles are concentrated, by current openings.
Regulatory Affairs Analyst Job Market in Indiana
A snapshot from current Indiana openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Healthcare & Medical Services
What Indiana Employers Look For
The qualifications that appear most often in regulatory affairs analyst jobs across Indiana.
- Bachelor's degree in life sciences, pharmacy, engineering, or a closely related field
- Working knowledge of FDA regulations including 21 CFR Parts 820 and 211
- Experience preparing or reviewing regulatory submissions such as 510(k), PMA, or NDA filings
- Familiarity with quality management systems and document control processes
- Strong technical writing skills for regulatory documents and SOPs
- RAC certification from the Regulatory Affairs Professionals Society preferred by many Indiana employers
Regulatory Affairs Analyst Jobs in Indiana: Frequently Asked Questions
How do you become a regulatory affairs analyst in Indiana?
A bachelor's degree in a life sciences, engineering, or pharmacy field is the standard entry point for regulatory affairs analyst roles in Indiana. Indiana does not issue a state-specific license for this role, so employers focus on academic background, knowledge of FDA regulations, and hands-on experience with submissions or quality systems. Earning the Regulatory Affairs Professionals Society RAC credential strengthens candidacy considerably with the large medical device and pharmaceutical employers concentrated in Indianapolis.
Which companies hire regulatory affairs analysts in Indiana?
Employers hiring regulatory affairs analysts in Indiana right now include Eli Lilly, Roche, and Elanco, based on current listings on Migrate Mate as of July 2026. Indiana's concentration of medical device manufacturers and pharmaceutical companies, anchored by the Indianapolis life sciences corridor, produces some of the most consistent regulatory hiring volume in the Midwest.
Which Indiana cities have the most regulatory affairs analyst jobs?
Indianapolis, Warsaw, and Bloomington account for the most regulatory affairs analyst openings in Indiana. Indianapolis dominates due to the dense cluster of pharmaceutical and medical device headquarters in the metro, while smaller markets like Columbus and South Bend appear because of major device manufacturers and healthcare system compliance functions based there.
Are there remote regulatory affairs analyst jobs in Indiana?
Yes, and more than most technical fields. Regulatory affairs work is largely document-driven and submission-based, which makes it well-suited to remote arrangements. About 11% of regulatory affairs analyst openings tied to Indiana are remote or hybrid as of July 2026, reflecting how broadly employers have accepted distributed work for this function. Submission writing, literature review, and dossier preparation are the tasks most commonly performed fully remote.
How can I get hired as a regulatory affairs analyst in Indiana with little or no experience?
The most realistic entry path is a quality assurance or regulatory affairs coordinator role at one of Indiana's medical device or pharmaceutical manufacturers, which routinely hire new graduates into document control and compliance support functions before moving them into analyst tracks. Eli Lilly and Zimmer Biomet both run structured early-career programs that feed into regulatory pipelines. A RAC-Associate credential or completion of a graduate certificate in regulatory affairs from Purdue or Indiana University gives candidates a concrete edge, and lateral moves from quality engineer or clinical trial coordinator roles are common in Indiana's device-heavy market.
Where can I find and apply to regulatory affairs analyst jobs in Indiana?
You can find and apply to regulatory affairs analyst jobs in Indiana on Migrate Mate, which lists current Indiana openings. Search the listings, identify the roles that match your background and target location, and apply directly to whichever ones fit your experience.
See All 14 Regulatory Affairs Analyst Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
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