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 11+ Regulatory Affairs Analyst jobs
Job Summary:
The Regulatory Affairs Manager is responsible for managing Regulatory Affairs activities across all functional areas – non-clinical, clinical, CMC, and advertising/promotional (Ad Promo) for both investigational and marketed products. This is a cross-functional role that partners with internal and external stakeholders to ensure strategic alignment and regulatory compliance throughout the product life cycle.
The ideal candidate will have a solid understanding of regulatory requirements across development and commercial stages, including INDs, CTAs, BLAs, global authority interactions, and promotional material review. This is a hands-on role in a fast-paced environment that requires flexibility, attention to detail, and strong communication skills.
Reporting to: Associate Director, Regulatory Affairs
Location: Remote - travel <15%
Responsibilities/Essential Duties:
- Manage the advertising and promotional submissions (2253s) related to the BLA and serve as the RA representative on the Promotional Review Committee.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Manage the preparation, review, and submission of regulatory documents across all modules (non-clinical, clinical and CMC) for IND/CTA, BLA/MAA, and other global submissions documents; may manage e-submission vendors.
- Collaborate on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, and annual reports).
- Ensure timely preparation of organized and scientifically valid applications.
- Interact with regulatory agencies on defined matters.
- Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
- Mentor, guide and train direct reports.
- May be required to travel up to 15%.
Basic Qualifications:
- Bachelor's degree & 5+ years' directly related experience.
- Direct experience in promotional material review and knowledge of FDA OPDP requirements.
Preferred Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field.
- Minimum 5-7 years' experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics.
- Regulatory Affairs certification or equivalent training.
- Experience in preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format.
- Knowledge of US, EU, Health Canada, Australia, and ICH regulatory requirements.
- Experience directly interfacing with regulatory authorities.
Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.
What Revance invests in you:
- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Job Summary:
The Regulatory Affairs Manager is responsible for managing Regulatory Affairs activities across all functional areas – non-clinical, clinical, CMC, and advertising/promotional (Ad Promo) for both investigational and marketed products. This is a cross-functional role that partners with internal and external stakeholders to ensure strategic alignment and regulatory compliance throughout the product life cycle.
The ideal candidate will have a solid understanding of regulatory requirements across development and commercial stages, including INDs, CTAs, BLAs, global authority interactions, and promotional material review. This is a hands-on role in a fast-paced environment that requires flexibility, attention to detail, and strong communication skills.
Reporting to: Associate Director, Regulatory Affairs
Location: Remote - travel <15%
Responsibilities/Essential Duties:
- Manage the advertising and promotional submissions (2253s) related to the BLA and serve as the RA representative on the Promotional Review Committee.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Manage the preparation, review, and submission of regulatory documents across all modules (non-clinical, clinical and CMC) for IND/CTA, BLA/MAA, and other global submissions documents; may manage e-submission vendors.
- Collaborate on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, and annual reports).
- Ensure timely preparation of organized and scientifically valid applications.
- Interact with regulatory agencies on defined matters.
- Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
- Mentor, guide and train direct reports.
- May be required to travel up to 15%.
Basic Qualifications:
- Bachelor's degree & 5+ years' directly related experience.
- Direct experience in promotional material review and knowledge of FDA OPDP requirements.
Preferred Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field.
- Minimum 5-7 years' experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics.
- Regulatory Affairs certification or equivalent training.
- Experience in preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format.
- Knowledge of US, EU, Health Canada, Australia, and ICH regulatory requirements.
- Experience directly interfacing with regulatory authorities.
Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.
What Revance invests in you:
- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
See All 11 Regulatory Affairs Analyst Jobs in Indiana
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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
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 November 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 and Warsaw 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 40% of regulatory affairs analyst openings tied to Indiana are remote or hybrid as of November 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 11 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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