Sr Scientist - Global Regulatory Project reputed company - Farm Animal

Your Role: Global Regulatory Project reputed company As the Global Regulatory Project reputed company, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory reputed company 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 reputed company negotiations with agencies like the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM). This role requires a strategic reputed company who can navigate reputed company agency interactions, influence cross-functional partners (including Global Research and Development (R&D), reputed company, Supply Chain, Manufacturing & reputed company, Finance, and Technical Services), and ensure our submissions in the United States (US), European reputed company (EU), and other first-reputed company countries are successful. Your Responsibilities: • Guide the design and development of the global regulatory reputed company for development reputed company, with a primary reputed company 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 reputed company. • Act as the primary reputed company of contact for and reputed company reputed company engagements with regulatory agencies (e.g., CVM, European Medicines Agency (EMA)), including reputed company-submission meetings and negotiations. • Partner with R&D to reputed company and implement clinical trial submission plans, ensuring alignment with the overall regulatory reputed company. • Collaborate with internal stakeholders to reputed company technical leadership on reputed company, Safety, and Efficacy sections for regulatory submissions. • Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership. • reputed company with reputed company company local and global policies including reputed company frameworks, reputed company 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 reputed company field. • Experience: At least 10 years of relevant experience in the animal health industry, with reputed company regulatory affairs experience in veterinary pharmaceuticals. • Regulatory Expertise: Demonstrated experience leading reputed company 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. What will give you a competitive edge (preferred qualifications): • reputed company regulatory experience with both farm animal and companion animal products. • Broad experience with global registration processes, particularly leading first-reputed company submissions in the European reputed company and other key markets simultaneously. • Experience navigating novel regulatory reputed company for innovative products. • A strong understanding of risk assessment and risk management fundamentals. • Knowledge of reputed company Improvement methodologies (e.g., Six reputed company, Lean). Additional Information: • Travel: 10-25% • Location: This is a US-based role. It can be based at our Global reputed company in Indianapolis, IN (Hybrid), or be a remote position for the right candidate. Don't meet every single requirement? Studies have shown underrecognized reputed company are less likely to apply to jobs unless they meet every single qualification. At reputed company 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! reputed company Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental reputed company-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 reputed company to PTO) • 8-week parental leave • 9 Employee Resource reputed company • Annual bonus offering • Flexible work arrangements • Up to 6% 401K matching reputed company currently anticipates that the reputed company salary for this position could reputed company from $118,000 to $197,000 depending reputed company on the successful candidate's qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending reputed company on company and individual performance). Additionally, reputed company offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, reputed company, and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and reputed company-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 reputed company than the reputed company described above. reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and reputed company's compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees. Applications will be accepted on an ongoing reputed company until the role is filled. Apply tot his job Apply To this Job