Regulatory Affairs Director Jobs in Indiana
Regulatory affairs director jobs in Indiana concentrate in life sciences, medical devices, and pharmaceutical manufacturing, sectors where the state has built a nationally recognized footprint anchored by companies like Eli Lilly, Cook Medical, and Zimmer Biomet. The strongest hiring metros are Indianapolis, Warsaw, and Fort Wayne, reflecting where Indiana's device and biopharma operations are densest. The most in-demand specialties are FDA submissions and compliance, quality systems management, and combination product regulation. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 11+ Regulatory Affairs Director 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 Director Jobs in Indiana
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Find JobsRegulatory Affairs Director Jobs by City in Indiana
Where Indiana roles are concentrated, by current openings.
Regulatory Affairs Director 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 director jobs across Indiana.
- Bachelor's degree in life sciences, engineering, or a related technical discipline required
- Minimum seven to ten years of regulatory affairs experience in medical devices or pharmaceuticals
- Demonstrated experience leading FDA submissions including 510(k), PMA, or NDA filings
- Proficiency with RAC or RAPS certification strongly preferred by Indiana employers
- Proven ability to manage cross-functional teams and direct regulatory strategy at a senior level
- Familiarity with ISO 13485, 21 CFR Part 820, and international regulatory frameworks
Regulatory Affairs Director Jobs in Indiana: Frequently Asked Questions
How do you become a regulatory affairs director in Indiana?
The path to a regulatory affairs director role in Indiana typically begins with a bachelor's degree in a life sciences or engineering field, followed by progressive experience in regulatory affairs within medical devices or pharmaceuticals. Indiana does not require a state-issued license specific to this role, but the Regulatory Affairs Certification (RAC) awarded by RAPS is the industry standard credential that Indiana employers, especially those in the Warsaw device corridor and Indianapolis biopharma hub, consistently look for at the director level.
How much do regulatory affairs directors make in Indiana?
Regulatory affairs directors 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 directors in Indiana?
Employers hiring regulatory affairs directors 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 in the Warsaw area and global pharmaceutical operations centered in Indianapolis means director-level regulatory roles appear consistently with large, established employers rather than being limited to startup activity.
Which Indiana cities have the most regulatory affairs director jobs?
The cities with the most regulatory affairs director openings in Indiana are Indianapolis and Warsaw. Indianapolis leads because it is home to Eli Lilly's global headquarters and a broad ecosystem of biopharma and diagnostics companies, while Warsaw draws significant hiring from the orthopedic and surgical device manufacturers that have made that region the recognized center of the global orthopedics industry.
Are there remote regulatory affairs director jobs in Indiana?
Yes, and more than many senior roles allow, given that much of a regulatory affairs director's work involves document strategy, submissions review, and agency correspondence that does not require physical presence. About 40% of regulatory affairs director openings tied to Indiana are remote or hybrid as of November 2026, though roles requiring direct oversight of manufacturing quality systems or on-site FDA audit response tend to require at least a hybrid schedule. Submissions-focused and global regulatory strategy roles are the most consistently remote-eligible.
How can I get hired as a regulatory affairs director in Indiana with little or no experience?
The most realistic entry path is a lateral move into a regulatory affairs specialist or coordinator role from an adjacent function such as quality assurance, clinical affairs, or scientific writing, which is how most Indiana director-level professionals built their foundation. Large Indiana device employers in Warsaw and Indianapolis regularly recruit quality and compliance professionals into entry regulatory roles where they gain submission and audit experience. Pursuing the RAC credential early and contributing to a 510(k) or NDA submission in any capacity, even in a support role, accelerates the progression toward director eligibility.
Where can I find and apply to regulatory affairs director jobs in Indiana?
You can find and apply to regulatory affairs director jobs in Indiana on Migrate Mate, which lists current Indiana openings updated regularly. Search the available roles, identify the ones that match your background and target location, and apply directly to the ones that fit.
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