Regulatory Affairs Jobs in Indiana
Regulatory affairs jobs in Indiana are steadily active, with the strongest demand concentrated in pharmaceutical manufacturing, medical device development, and life sciences, drawing candidates from entry-level compliance associates through senior regulatory managers. Indianapolis anchors the market, while Bloomington and Fort Wayne add meaningful volume through established life sciences and manufacturing employers such as Eli Lilly, Cook Medical, and Zimmer Biomet. The most sought-after specialties are FDA submissions, quality systems compliance, and drug or device labeling. See the openings below and apply to the ones that match your experience.
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Showing 5 of 11+ Regulatory Affairs 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 Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
Find Regulatory Affairs JobsRegulatory Affairs Jobs by City in Indiana
Where Indiana roles are concentrated, by current openings.
Regulatory Affairs 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 jobs across Indiana.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related technical field
- Experience with FDA submissions including 510(k), PMA, NDA, or BLA filings
- Working knowledge of 21 CFR regulations governing drugs, biologics, or medical devices
- Familiarity with quality management systems and ISO 13485 or ICH guidelines
- Strong technical writing skills for regulatory documents, dossiers, and SOPs
- Proficiency with regulatory information management or document control software platforms
Regulatory Affairs Jobs in Indiana: Frequently Asked Questions
How do you become a regulatory affairs professional in Indiana?
Most regulatory affairs roles in Indiana require a bachelor's degree in a life sciences, pharmacy, or engineering field, and the state does not issue a separate regulatory affairs license. Employers in Indiana's pharmaceutical and medical device sectors, including those in Indianapolis and Bloomington, typically expect candidates to hold or pursue the Regulatory Affairs Certification offered by the Regulatory Affairs Professionals Society, which signals validated competency in FDA and international regulatory frameworks.
How much do regulatory affairses make in Indiana?
Regulatory affairses in Indiana earn a median of about $78,770 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $47,650 for the lowest 10% to over $134,820 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs professionals in Indiana?
Employers hiring regulatory affairs professionals in Indiana right now include Eli Lilly, Roche, and Elanco, based on current listings on Migrate Mate as of November 2026. Indiana's deep concentration of pharmaceutical headquarters and medical device manufacturers means openings appear across both large multinationals and specialized mid-size companies anchored in the Indianapolis and Bloomington corridors.
Which Indiana cities have the most regulatory affairs jobs?
The cities with the most regulatory affairs openings in Indiana are Indianapolis and Warsaw. Indianapolis dominates because it is home to Eli Lilly's global headquarters and a dense cluster of contract research organizations and device firms, while Bloomington and Warsaw generate steady demand through Cook Medical, Zimmer Biomet, and an ecosystem of orthopedic and surgical device manufacturers that have operated there for decades.
Are there remote regulatory affairs jobs in Indiana?
Yes, and more than most fields. Regulatory affairs work is primarily documentation-driven and does not require routine on-site lab or manufacturing presence, making it well-suited for remote and hybrid arrangements. About 40% of regulatory affairs openings tied to Indiana are remote or hybrid as of November 2026, reflecting a broad shift among pharmaceutical and device employers post-pandemic. Submissions writing, labeling review, and regulatory strategy roles are most commonly offered on flexible location terms.
How can I get hired as a regulatory affairs professional in Indiana with little or no experience?
The most realistic entry path is through a quality assurance or regulatory compliance associate role at one of Indiana's pharmaceutical or medical device manufacturers, where hands-on exposure to SOPs, document control, and FDA audit preparation builds transferable credentials. Eli Lilly, Cook Medical, and Roche Diagnostics all run structured rotational or early-career programs from their Indiana sites. Candidates who pair a life sciences degree with coursework in regulatory affairs or pursue the RAC credential through the Regulatory Affairs Professionals Society stand out in Indiana applicant pools, as do those with internship experience in a GMP-regulated environment.
Where can I find and apply to regulatory affairs jobs in Indiana?
You can find and apply to regulatory affairs jobs in Indiana on Migrate Mate, which lists current Indiana openings updated regularly. Search the listings for roles that match your background in pharmaceuticals, medical devices, or biologics, then apply directly to the ones that fit your experience level and preferred location.
See All 11 Regulatory Affairs Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
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