Global Regulatory Project Lead - Biologicals

Indiana Ag Connection; Union (NJ); On-site; USD 118,000 - 197,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (mid-summer and

8-week parental leave

401K matching

Job summary

Elanco is seeking a Global Regulatory Project Lead - Biologicals to drive regulatory strategy for farm and companion animal products on a global scale. You will act as the regulatory expert on project teams, guide submissions, and negotiate with agencies including the USDA CVB.

You will collaborate with R&D, Sales, Supply Chain, and Quality to ensure compliant, timely submissions across US, EU, and key markets, with travel anticipated (10–25%).

Qualifications

• Master's degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or related field.
• 10+ years of relevant animal health regulatory affairs experience.
• Experience leading regulatory submissions and negotiations with agencies (CVB preferred).

Responsibilities

• Guide the global regulatory strategy for development projects, focusing on CVB submissions.
• Serve as regulatory expert on development teams and provide risk/benefit evaluations.
• Lead direct engagements with regulatory agencies and interact with cross-functional partners.

Skills

Regulatory leadership

USDA CVB submissions

Cross-functional leadership

Regulatory strategy

Education

Master's degree or higher in veterinary medicine/biology/immunology/animal science

Job description

### Job Details#### Job Title:Global Regulatory Project Lead - Biologicals#### Location:,, ,#### Company:#### Industry Sector:#### Industry Type:#### Career Type:#### Job Type:Full Time#### Minimum Years Experience Required:N/A#### Salary:### Get Job Alerts**Career Type:****Country:** USAI agree to receive alerts from and to the .Your alert was created successfully.x## General Alert Saved* The listings below are jobs matching the criteria you've selected for your General Alert on.Criteria selected was:* General alert saved for .* General alert notifications will be sent weekly on Monday.* Please note that you can only have one general alert active at any given time. Creating a new general alert will override an existing general alert.* Visit the to manage your alerts# Global Regulatory Project Lead - Biologicals| Number of Years Experience: | Minimum Education Completed: | || Education Major / Discipline Category: | Most Recent / Current Occupation: | |**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!****Company Overview:**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. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose(TM)- to advance the health of animals, people, the planet, and our enterprise.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:** Global Regulatory Project Lead - BiologicalsAs 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 biological 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 USDA's Center for Veterinary Biologics (CVB). 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 CVB 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.* 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.**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 biologicals.* Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the USDA - Center of Veterinary Biologics (CVB).* 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.**What will give you a competitive edge (preferred qualifications):*** Direct USDA-CVB regulatory experience with both farm animal and companion animal products.* Experience navigating novel regulatory pathways for innovative products.* Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.* 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%**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#LI-SC1Elanco 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. Estimated application closing date is (insert date). Applications will be accepted on an ongoing basis.Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation,