Demonstratedability to guide cross-functional project teams through complex regulatory submissions and manage interactions with agencies like the FDA and USDA. What will give you a competitive edge ...
Demonstratedability to guide cross-functional project teams through complex regulatory submissions and manage interactions with agencies like the FDA and USDA. What will give you a competitive edge ...
Regulatory Affairs Specialist
Carmel, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Carmel, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Evansville, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Evansville, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Fort Wayne, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Fort Wayne, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Indianapolis, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Indianapolis, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
South Bend, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
South Bend, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Fishers, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Regulatory Affairs Specialist
Fishers, IN · Remote
$50 - $70/hr
Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to ...
Automation Engineer
Indianapolis, IN · On-site
Knowledgeable on regulatory requirements, FDA 21 CFR 820/GMP Medical Device Regulations. * Working knowledge of Minitab. * Knowledge of statistical techniques and sampling for process validation and ...
Automation Engineer
Indianapolis, IN · On-site
Knowledgeable on regulatory requirements, FDA 21 CFR 820/GMP Medical Device Regulations. * Working knowledge of Minitab. * Knowledge of statistical techniques and sampling for process validation and ...
Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. Ensure that complete and accurate records are ...
Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. Ensure that complete and accurate records are ...
Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies * Drive planning, preparation, and submission of regulatory ...
Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies * Drive planning, preparation, and submission of regulatory ...
Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies * Drive planning, preparation, and submission of regulatory ...
Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies * Drive planning, preparation, and submission of regulatory ...
Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. * Ensure that complete and accurate records are ...
Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. * Ensure that complete and accurate records are ...
Must understand FDA regulations.
Quick apply
Must understand FDA regulations.
Regulatory Coordinator | On-site, Indianapolis, IN
Indianapolis, IN · On-site
$60K - $70K/yr
Understanding and experience with US FDA, and ISO Regulatory requirements. * Ability to work independently and cope with changing priorities, and to prioritize workload to meet datelines. * 3+ years ...
Quick apply
Regulatory Coordinator | On-site, Indianapolis, IN
Indianapolis, IN · On-site
$60K - $70K/yr
Understanding and experience with US FDA, and ISO Regulatory requirements. * Ability to work independently and cope with changing priorities, and to prioritize workload to meet datelines. * 3+ years ...
FSQA Manager
Morristown, IN · On-site
Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. * Ensure that complete and accurate records are ...
FSQA Manager
Morristown, IN · On-site
Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. * Ensure that complete and accurate records are ...
Quality Control Technician
Fishers, IN · On-site
$30/hr
Strong knowledge of QA/QC processes, ISO 13485 standards, FDA regulations, and HACCP principles. * Excellent analytical skills with the ability to interpret data effectively. * Detail-oriented ...
Quick apply
Quality Control Technician
Fishers, IN · On-site
$30/hr
Strong knowledge of QA/QC processes, ISO 13485 standards, FDA regulations, and HACCP principles. * Excellent analytical skills with the ability to interpret data effectively. * Detail-oriented ...
Adhere to regulatory standards: Ensure strict compliance with FDA regulations, including 21 CFR Part 111 (dietary supplements) and 21 CFR Part 117 (food safety), as well as cGMPs for dietary ...
Adhere to regulatory standards: Ensure strict compliance with FDA regulations, including 21 CFR Part 111 (dietary supplements) and 21 CFR Part 117 (food safety), as well as cGMPs for dietary ...
Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVM/FDA submissions. * Serve as the dedicated regulatory subject matter expert on ...
Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVM/FDA submissions. * Serve as the dedicated regulatory subject matter expert on ...
Adhere to regulatory standards: Ensure strict compliance with FDA regulations, including 21 CFR Part 111 (dietary supplements) and 21 CFR Part 117 (food safety), as well as cGMPs for dietary ...
Adhere to regulatory standards: Ensure strict compliance with FDA regulations, including 21 CFR Part 111 (dietary supplements) and 21 CFR Part 117 (food safety), as well as cGMPs for dietary ...
Be Seen First
Follow Good Clinical Practice (GCP), FDA regulations, study protocols, and MediSphere Standard Operating Procedures. * Assist with sponsor monitoring visits, audits, and regulatory inspections.
Quick apply
Be Seen First
Follow Good Clinical Practice (GCP), FDA regulations, study protocols, and MediSphere Standard Operating Procedures. * Assist with sponsor monitoring visits, audits, and regulatory inspections.
Fda Regulatory information
See Indiana salary details
$18.07 - $21.83
3% of jobs
$21.83 - $25.60
6% of jobs
$25.60 - $29.36
13% of jobs
$29.86 is the 25th percentile. Wages below this are outliers.
$29.36 - $33.13
20% of jobs
The median wage is $34.59 / hr.
$33.13 - $36.89
19% of jobs
$36.89 - $40.65
9% of jobs
$42.54 is the 75th percentile. Wages above this are outliers.
$40.65 - $44.42
10% of jobs
$44.42 - $48.18
6% of jobs
$48.18 - $51.94
5% of jobs
$51.94 - $55.71
5% of jobs
$55.71 - $59.47
3% of jobs
$18
$37
$59
How much do fda regulatory jobs pay per hour?
As of Aug 10, 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:
Full-time
Retirement, PTO
Re-posted 3 days ago
Elanco rating
7.8
Based on 25 frontline employees who took The Breakroom Quiz
51st of 86 rated pharmaceutical
Job description
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Feed Additive Regulatory Specialist
The Feed Additive Regulatory Specialist is a technical leadership role responsible for the operational execution of regulatory affairs for Elanco's US Feed Additive and Nutritional Health portfolio. This individual provides the technicalexpertiserequiredto define registration requirements and ensures that all product development packages align with regulatory expectations.
As a key technical leader, you will play a vital role in the lifecycle management of registered products, guiding project teams to address post-approvalmandatesandprovidingcritical regulatory guidance for promotional materials. This role acts as a bridge between global technical functions and the US Affiliate, ensuring that Elancoremainscompliant with all federal and state regulations whilemaintainingpositive collaborations with regulatory agencies and industry trade groups.
Your Responsibilities:
Regulatory Execution & Commercial Partnership:Oversee lifecycle management for the US feed additive portfolio,providingexpert regulatory guidance on promotional materials and ensuring all commercial activitiesremaincompliant.
Technical Leadership & Project Management:Apply sound scientific approaches to define registration requirements (Safety, Efficacy, CMC, Labeling) and guide project teams by coordinating internal and external resources to meet submission standards.
Cross-functional Collaboration & External Influence:Serve as the primary regulatory contact withauthorities, andcollaborate with global teams and industry groups (AAFCO, AFIA) to shape policies and ensure internal compliance.
Quality & Compliance:Ensure all regulatory activities and documentation adhere to Elanco's Quality Management System (QMS), SOPs, and industry best practices.
What You Need to Succeed (minimum qualifications):
Education:Bachelor's degree in Chemistry, Biochemistry, Animal Science, oran equivalentscientific discipline.
Experience:A minimum of 5 years of regulatory experience in the nutritional health, feed additive, or sustainability industry, with proven experience managing US technical submissions and interacting with regulatory agencies (e.g., FDA, USDA).
Top Skills:
Technical Expertise:In-depth knowledge of US registration pathways and requirements for feed additives and nutritional health products, including CMC, Safety, Efficacy, and GRAS.
Project Leadership:Demonstratedability to guide cross-functional project teams through complex regulatory submissions and manage interactions with agencies like the FDA and USDA.
What will give you a competitive edge (preferred qualifications):
An advanced degree (Mastersor PhD) in a relevant scientific discipline.
Direct experience with specific feed additive categories such as enzymes, probiotics, or products related to sustainability (e.g., methane reduction).
Demonstrated experience managing complex, non-standard regulatoryrequestsand guiding projects to completion under tight timelines.
Effective negotiation and influencing skills, with experience in direct communications with health authorities and industry associations.
High levelofproficiencyin regulatory information management systems (e.g., Veeva Vault RIM) and electronic submission platforms.
Additional Information:
Travel:10% or less
Location:Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
Don'tmeet every single requirement? Studies have shown underrecognized groups are less likely to applytojobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role butdon'tnecessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against jobrelated criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
About Elanco
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
5,001 - 10,000 Employees
Headquarters location
Greenfield, IN, US
Year founded
1954