Senior Scientist – Global Regulatory Project Lead, Farm Animal

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the creation and advancement of a global regulatory strategy for development initiatives, with a primary emphasis on CVM/FDA submissions.

• Act as the primary regulatory subject matter expert within development teams.

• Provide risk and benefit assessments to inform project strategies.

• Lead direct interactions with regulatory agencies, including pre-submission discussions and negotiations.

• Collaborate with R&D to formulate and execute clinical trial submission strategies.

• Work with internal stakeholders to provide technical leadership for the Quality, Safety, and Efficacy sections of regulatory submissions.

• Identify and relay project-specific regulatory risks and opportunities to development teams and leadership.

• Influence cross-functional partners across R&D, Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services.

• Adhere to company local and global policies.

⛳️ Requirements

• Master's degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related discipline.

• A minimum of 10 years of pertinent experience in the animal health sector.

• Direct experience in regulatory affairs related to veterinary pharmaceuticals.

• Proven track record of leading direct submissions and negotiations with regulatory bodies.

• Strong preference for experience with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM).

• Demonstrated ability to act as the primary regulatory expert on cross-functional project teams in a global context.

• Excellent communication, negotiation, and influencing capabilities.

• Direct regulatory experience with both farm animal and companion animal products is preferred.

• Extensive experience with global registration processes, particularly in leading first-wave submissions in the European Union and other key markets concurrently is preferred.

• Experience in navigating novel regulatory pathways for innovative products is preferred.

• Strong understanding of risk assessment and risk management principles is preferred.

• Familiarity with Continuous Improvement methodologies, such as Six Sigma and Lean, is preferred.

• Ability to comply with company local and global policies, including quality frameworks, Code of Conduct, anti-discrimination, harassment, and HSE policies.

🏝️ Benefits

• 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.

• Vacation benefits.

• Medical, dental, vision, and prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities.