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Director Regulatory Operations Jobs in Indiana (NOW HIRING)

Centria Autism

Operations Director

Speedway, IN

The Operations Director will lead Behavior Technicians by coordinating training and compliance ... Maintain Compliance Regulations * Enforce compliance with center policies and procedures ...

Centria Autism

Operations Director

Speedway, IN · On-site

The Operations Director will lead Behavior Technicians by coordinating training and compliance ... Maintain Compliance Regulations * Enforce compliance with center policies and procedures ...

Socket.dev

Operations Director

Lebanon, IN · On-site

$144.50 - $195.50/hr

Title Operations Director Job Overview The Operations Director will be responsible for directing ... Ensure compliance with local, state, and federal regulations, such as FLSA, OSHA, ADA, etc.

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Director Regulatory Operations information

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$32.4K

$102.5K

$170.8K

How much do director regulatory operations jobs pay per year?

As of Aug 9, 2026, the average yearly pay for director regulatory operations in Indiana is $102,465.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,800.00 and $128,900.00 per year, depending on experience, location, and employer.

What are the typical responsibilities and team dynamics for a director regulatory operations?

As a Director Regulatory Operations, your primary responsibilities include overseeing the preparation and submission of regulatory documents, ensuring compliance with global standards, and leading process improvement initiatives. You will usually manage a team of regulatory professionals and collaborate closely with clinical, quality, and legal departments to align regulatory strategies with business goals. The role often involves managing multiple projects simultaneously, tracking submission timelines, and anticipating regulatory challenges. This is a fast-paced position offering leadership opportunities and the potential to advance to executive roles within regulatory affairs or related departments.

What are the key skills and qualifications needed to thrive in the director regulatory operations position, and why are they important?

To excel as a Director Regulatory Operations, you need comprehensive knowledge of regulatory affairs, quality systems, and project management, usually supported by an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems (such as eCTD), document management platforms, and certifications like RAC (Regulatory Affairs Certification) are commonly required. Outstanding organizational skills, strategic leadership, and the ability to communicate and negotiate effectively are essential soft skills. These competencies ensure efficient regulatory compliance, timely submissions, and effective coordination across cross-functional teams in a highly regulated environment.

What does a director regulatory operations do?

A Director of Regulatory Operations oversees the development, submission, and management of regulatory documents to ensure compliance with industry regulations. They lead regulatory teams, streamline processes, and collaborate with internal stakeholders to meet regulatory requirements efficiently. Their responsibilities often include managing electronic submissions, maintaining regulatory information systems, and staying updated on changing regulatory guidelines.

What are the most commonly searched types of Regulatory Operations jobs in Indiana? The most popular types of Regulatory Operations jobs in Indiana are:
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Director Regulatory Operations jobs near you

Associate Director, Regulatory Affairs - Biologics

Elanco Animal Health Incorporated

Indianapolis, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 4 days ago

Elanco rating

7.8

Company rating: 7.8 out of 10

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
As Associate Director, Regulatory Affairs - Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. This role guides regulatory activities across development and lifecycle management, partnering closely with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.
The ideal candidate brings experience in biologics, vaccines, biotechnology, or pharmaceutical regulatory affairs and has supported regulatory strategy, health authority interactions, and regulatory submissions. Experience in Animal Health is valued but not required.
This is an opportunity to apply your biologics regulatory expertise to innovative development programs while helping advance products that improve animal health globally.
Your Responsibilities
  • Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management activities
  • 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 dossiers, agency responses, and supporting documentation
  • Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management
  • Partner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goals

What You Need to Succeed (minimum qualifications)
  • Education: Bachelor's degree in a scientific or technical discipline required
  • Experience: Minimum of 5 years of Regulatory Affairs experience within biologics, vaccines, biotechnology, pharmaceutical, or other regulated life science environments
  • Experience supporting regulatory strategy, regulatory submissions, health authority interactions, or agency responses
  • Knowledge of biologics development, manufacturing processes, and product lifecycle management
  • Ability to work cross-functionally and influence decisions in a matrixed environment

What Will Give You a Competitive Edge (preferred qualifications)
  • Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related regulatory environments
  • Experience in Biologics CMC Regulatory Affairs
  • Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH regulatory requirements
  • Experience supporting manufacturing changes, tech transfer, or post-approval regulatory activities
  • Experience supporting global or multi-regional regulatory programs

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
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).
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.
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 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.

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