Senior Level Regulatory Coordinator Jobs
Senior level regulatory coordinator jobs place experienced professionals in charge of regulatory strategy, end-to-end submission ownership, and the cross-functional teams that keep compliance programs on track. Openings are concentrated in Biotechnology & Pharmaceuticals, Consulting & Professional Services, and Medical Devices, with a mix of on-site, hybrid, and remote roles available, and employers like Revolution Medicines, Revolution Medicines, and ImmunityBio hiring at this level now.
Find JobsOverview
Showing 5 of 103+ Senior Level Regulatory Coordinator jobs
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!
Position Description:
The Advisor, CMC Regulatory Affairs – Biologicals for Elanco Animal Health is responsible for providing regulatory guidance resulting in comprehensive, cohesive, and compliant submissions and interactions to maintain product registrations and product availability. The individual in this role interacts with regulators and internal stakeholders to drive regulatory solutions.
The Advisor, CMC Regulatory Affairs – Biologicals will initiate strategies and follow-up on process improvements and commitments. Additionally, the individual in this role will focus on interacting positively while developing relationships with internal and external stakeholders including Manufacturing, Quality, R&D, and third party and trade association groups. The individual in this role is expected to perform key leadership responsibilities, which provide innovative solutions, a positive and motivating work environment, to ultimately deliver the Elanco pipeline and maintain established product registrations and regulatory availability.
Functions, Duties, Task:
Key Technical Responsibilities:
- Responsible for having a thorough understanding of the regulations to work independently within a cross-functional team.
- Anticipates and resolves complex problems to maintain product to market.
- Subject matter expertise to advise QC, QA, and Manufacturing on regulatory aspects.
- Ensure inspection readiness from regulatory perspective.
- Build tools, systems, and business processes to develop best capabilities.
- Writes and reviews submissions to ensure they are scientifically sound, accurate, and compliant in close collaboration with Subject Matter Experts.
- Coordinate, supervise and review commitment responses. Actively participates in meetings that drive strategy and outcomes.
Key Leadership Responsibilities:
- Proactively search for opportunities for continuous improvement and facilitate implementation of new standards and practices with the ability to think “out of the box”.
- Deliver regulatory solutions and opportunities while creating an innovative culture.
- Work effectively and flexibly within and across all Elanco teams, external collaborators, government agencies, and affiliates to assist in achieving overall Elanco deliverables.
- Create a positive, engaging, and inspiring work environment that is aligned with company objectives.
- Influence others to adopt a different view to create an innovative culture.
- Create an engaging culture and identify essential wins.
- Excellent interpersonal and communication skills.
Minimum Qualification (education, experience and/or training, required certifications):
- Master’s degree at a minimum
- Minimum 8 years in a veterinary vaccine / biological manufacturing setting
Additional Preferences:
- Strong understanding of varied regulatory requirements (e.g., US FDA, EMA, etc.) related to veterinary biological manufacturing.
Don’t meet every single requirement? Studies have shown underrepresented 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 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.
#LI-RH1
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.
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!
Position Description:
The Advisor, CMC Regulatory Affairs – Biologicals for Elanco Animal Health is responsible for providing regulatory guidance resulting in comprehensive, cohesive, and compliant submissions and interactions to maintain product registrations and product availability. The individual in this role interacts with regulators and internal stakeholders to drive regulatory solutions.
The Advisor, CMC Regulatory Affairs – Biologicals will initiate strategies and follow-up on process improvements and commitments. Additionally, the individual in this role will focus on interacting positively while developing relationships with internal and external stakeholders including Manufacturing, Quality, R&D, and third party and trade association groups. The individual in this role is expected to perform key leadership responsibilities, which provide innovative solutions, a positive and motivating work environment, to ultimately deliver the Elanco pipeline and maintain established product registrations and regulatory availability.
Functions, Duties, Task:
Key Technical Responsibilities:
- Responsible for having a thorough understanding of the regulations to work independently within a cross-functional team.
- Anticipates and resolves complex problems to maintain product to market.
- Subject matter expertise to advise QC, QA, and Manufacturing on regulatory aspects.
- Ensure inspection readiness from regulatory perspective.
- Build tools, systems, and business processes to develop best capabilities.
- Writes and reviews submissions to ensure they are scientifically sound, accurate, and compliant in close collaboration with Subject Matter Experts.
- Coordinate, supervise and review commitment responses. Actively participates in meetings that drive strategy and outcomes.
Key Leadership Responsibilities:
- Proactively search for opportunities for continuous improvement and facilitate implementation of new standards and practices with the ability to think “out of the box”.
- Deliver regulatory solutions and opportunities while creating an innovative culture.
- Work effectively and flexibly within and across all Elanco teams, external collaborators, government agencies, and affiliates to assist in achieving overall Elanco deliverables.
- Create a positive, engaging, and inspiring work environment that is aligned with company objectives.
- Influence others to adopt a different view to create an innovative culture.
- Create an engaging culture and identify essential wins.
- Excellent interpersonal and communication skills.
Minimum Qualification (education, experience and/or training, required certifications):
- Master’s degree at a minimum
- Minimum 8 years in a veterinary vaccine / biological manufacturing setting
Additional Preferences:
- Strong understanding of varied regulatory requirements (e.g., US FDA, EMA, etc.) related to veterinary biological manufacturing.
Don’t meet every single requirement? Studies have shown underrepresented 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 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.
#LI-RH1
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 103+ Senior Level Regulatory Coordinator Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsSenior Level Regulatory Coordinator Job Market
Who's Hiring
- Revolution Medicines28
- ImmunityBio3
- Nurix Therapeutics3
- Insmed Incorporated3
Top Industries Hiring
- Biotechnology & Pharmaceuticals57
- Consulting & Professional Services9
- Medical Devices5
- Distribution & Wholesale5
- Technology & Software4
Senior Level Regulatory Coordinator Jobs: Frequently Asked Questions
How do I get a senior level regulatory coordinator job?
Employers at this level want candidates who have owned regulatory submissions from start to approval, not just supported them. Demonstrating that you've led cross-functional teams, authored regulatory strategies, and resolved agency queries independently signals readiness. A history of mentoring junior coordinators and managing complex filing timelines across multiple product lines or programs gives your application a clear edge over generalist candidates.
Which companies hire senior level regulatory coordinators?
Companies hiring senior level regulatory coordinators right now include Revolution Medicines, Revolution Medicines, and ImmunityBio, based on current listings on Migrate Mate as of November 2026. Hiring at this level tends to concentrate among mid-size to large organizations with active product pipelines, compliance-heavy operations, or dedicated regulatory affairs departments that need experienced professionals to lead submissions and guide strategy.
Are there remote senior level regulatory coordinator jobs?
Yes, though availability varies by industry and employer. About 31% of senior level regulatory coordinator openings are remote or hybrid as of November 2026, with hybrid arrangements being more common at organizations that require periodic on-site collaboration with regulatory teams, quality assurance, or executive stakeholders. Fully remote roles do exist, particularly at companies with distributed regulatory functions.
What makes a regulatory coordinator role senior level?
Senior level regulatory coordinator roles are defined by ownership, not just execution. At this stage, you are expected to set regulatory strategy for programs or product lines, make independent decisions on submission approaches, and serve as a subject-matter resource for other teams. Mentoring junior staff, managing agency relationships, and driving process improvements within the regulatory function are hallmarks that distinguish these roles from mid-level positions.
Which industries hire the most senior level regulatory coordinators?
Senior Level regulatory coordinator roles concentrate in Biotechnology & Pharmaceuticals, Consulting & Professional Services, and Medical Devices, based on current listings on Migrate Mate as of November 2026. These sectors drive hiring at this level because they operate under rigorous federal and international regulatory frameworks, requiring experienced coordinators who can own complex compliance programs and guide organizations through evolving agency requirements.