H-1B Visa Lead Scientist Jobs
Lead Scientist jobs with H-1B visa sponsorship sit firmly within specialty occupation territory: the role requires at least a bachelor's degree in a directly related scientific field, satisfying USCIS's core criterion. Employers must file a certified LCA with DOL and an I-129 petition with USCIS before your start date.
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Get Access To All JobsINTRODUCTION
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!
ROLE AND RESPONSIBILITIES
Global Regulatory Project Lead
As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory strategy for novel farm and companion animal products. You will serve as the dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies like the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM). This role requires a strategic professional who can navigate complex agency interactions, influence cross-functional partners (including Global Research and Development (R&D), Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other first-wave countries are successful.
Your Responsibilities:
- 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 development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
- Act as the primary point of contact for and lead direct engagements with regulatory agencies (e.g., CVM, European Medicines Agency (EMA)), including pre-submission meetings and negotiations.
- Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
- Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
- Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.
BASIC QUALIFICATIONS
What You Need to Succeed (minimum qualifications):
- Education: A Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.
- Experience: At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary pharmaceuticals.
- Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM).
- Guidance & Influence: Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.
PREFERRED QUALIFICATIONS
What will give you a competitive edge (preferred qualifications):
- Direct regulatory experience with both farm animal and companion animal products.
- Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
- Experience navigating novel regulatory pathways for innovative products.
- A strong understanding of risk assessment and risk management fundamentals.
- Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).
ADDITIONAL INFORMATION
- Travel: 10-25%
- Location: This is a US-based role. It can be based at our Global Headquarters in Indianapolis, IN (Hybrid), or be a remote position for the right candidate.
LI-SC1
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs 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 but don't necessarily 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 currently anticipates that the base salary for this position could range from $118,000 to $197,000 depending partly on the successful candidate's qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees. Applications will be accepted on an ongoing basis until the role is filled.
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 job-related 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.
INTRODUCTION
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!
ROLE AND RESPONSIBILITIES
Global Regulatory Project Lead
As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory strategy for novel farm and companion animal products. You will serve as the dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies like the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM). This role requires a strategic professional who can navigate complex agency interactions, influence cross-functional partners (including Global Research and Development (R&D), Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other first-wave countries are successful.
Your Responsibilities:
- 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 development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
- Act as the primary point of contact for and lead direct engagements with regulatory agencies (e.g., CVM, European Medicines Agency (EMA)), including pre-submission meetings and negotiations.
- Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
- Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
- Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.
BASIC QUALIFICATIONS
What You Need to Succeed (minimum qualifications):
- Education: A Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.
- Experience: At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary pharmaceuticals.
- Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM).
- Guidance & Influence: Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.
PREFERRED QUALIFICATIONS
What will give you a competitive edge (preferred qualifications):
- Direct regulatory experience with both farm animal and companion animal products.
- Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
- Experience navigating novel regulatory pathways for innovative products.
- A strong understanding of risk assessment and risk management fundamentals.
- Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).
ADDITIONAL INFORMATION
- Travel: 10-25%
- Location: This is a US-based role. It can be based at our Global Headquarters in Indianapolis, IN (Hybrid), or be a remote position for the right candidate.
LI-SC1
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs 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 but don't necessarily 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 currently anticipates that the base salary for this position could range from $118,000 to $197,000 depending partly on the successful candidate's qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees. Applications will be accepted on an ongoing basis until the role is filled.
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 job-related 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.
See all 822+ H-1B Visa Lead Scientist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Lead Scientist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Lead Scientist
Align your degree to your scientific discipline
USCIS scrutinizes whether your specific degree field directly maps to your Lead Scientist duties. A chemistry degree supporting a biochemistry research role is clean; a general biology degree for a materials science position may trigger a Request for Evidence. Document the connection explicitly in your resume and during offer negotiations.
Verify prevailing wage before accepting an offer
Your employer must certify your wage meets or exceeds the DOL prevailing wage for your specific SOC code and worksite location. Run your role through the OFLC Wage Search before the offer stage so you can flag underpayment issues before the LCA is filed, not after.
Target employers with multi-site LCA infrastructure
Lead Scientist roles often involve fieldwork, partner labs, or satellite facilities. Each worksite requires its own certified LCA. Prioritize employers whose HR teams understand this requirement and have filed LCAs across multiple locations, since a missing worksite LCA puts your status at immediate risk.
Search Migrate Mate for verified H-1B sponsors
Find employers with confirmed H-1B LCA filing history for scientific research roles on Migrate Mate. Focusing your search on organizations that have already navigated the specialty occupation determination for Lead Scientist positions cuts negotiation friction and shortens the path from offer to petition filing.
Review your O*NET profile before your USCIS filing
The O*NET occupation profile for your SOC code describes the degree requirements and core tasks USCIS adjudicators reference. Confirm your job description mirrors the specialized duties listed there. Gaps between your offer letter and the O*NET profile are a common RFE trigger for research scientist petitions.
Plan your cap selection timeline with your employer
H-1B cap selection rules have changed recently. Confirm your employer knows the current registration window and petition deadline from USCIS before you finalize a start date. A Lead Scientist role at a cap-exempt institution, such as a nonprofit research organization or university, bypasses the cap entirely.
H-1B Visa Lead Scientist: Frequently Asked Questions
Does a Lead Scientist role qualify as a specialty occupation for H-1B purposes?
Yes. Lead Scientist positions typically require at least a bachelor's degree in a directly related scientific discipline, such as biology, chemistry, physics, or materials science, which meets USCIS's specialty occupation definition. Your employer should document the degree requirement in the job description and confirm it in the LCA to support a clean petition.
How do I find employers who actively sponsor H-1B visas for Lead Scientist roles?
Migrate Mate lists employers with verified H-1B LCA filing history, so you can browse organizations that have already sponsored scientific research roles rather than guessing at sponsorship willingness. Pharmaceutical companies, federal contractors, national laboratories, and research universities are common H-1B sponsors for Lead Scientist positions.
What happens to my H-1B status if my Lead Scientist role changes scope mid-employment?
A material change in job duties, location, or salary can require your employer to file an amended H-1B petition with USCIS and, if the worksite changes, a new certified LCA with DOL before the change takes effect. Expanding into a different scientific specialty or taking on a supervisory title that shifts your SOC code triggers the same requirement.
Can I transfer my H-1B to a new employer while between Lead Scientist contracts?
Yes, through H-1B portability. If you've been in valid H-1B status and your new employer files a non-frivolous petition before your current status expires, you can begin working for the new employer once the petition is received by USCIS. The 60-day grace period after your previous role ends gives you a window to arrange the transfer.
How long does it take for an employer to complete H-1B sponsorship for a Lead Scientist hire?
DOL certifies most LCAs within seven business days. USCIS standard processing for the I-129 petition runs several months, though premium processing accelerates the decision to 15 business days for an additional fee. Build at least three to four months of lead time into your start date conversation with any sponsoring employer.