Global Regulatory Project Lead - Global Regulatory Affairs

Responsibilities

• Strategy & Technical Leadership: Lead the design and development of regulatory strategies and technical documentation. Provide technical leadership to ensure timely compliance and successful delivery of global development projects.
• Project Oversight & Risk Management: Manage and prioritize resources to meet project timelines and objectives. Proactively identify and communicate project-specific risks, opportunities, and impacts to internal stakeholders.
• Cross-Functional Collaboration: Represent the regulatory viewpoint on development and governance teams, providing insight into product development, target labels, and registration. Influence strategies through collaboration with R&D, Global Marketing, Legal, and Manufacturing & Quality.
• Clinical & Quality Compliance: Enable the development of clinical trial submission plans with R&D and review project-related communications. Initiate the generation and review of policies, SOPs, and guidance to ensure compliance with National Competent Authority regulations.
• Meeting Leadership: Lead team meetings regarding Quality, Safety, and Effectiveness technical sections during regulatory agency interactions, or support team members in these activities as required.
• Policy & Ethics: Comply with all company local and global policies, including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and Health, Safety, and Environment (HSE) standards
• What You Need to Succeed (minimum qualifications):
• Education: Master's degree or higher in Veterinary Medicine, Biology, Infectious Diseases, Immunology, or a related field.
• Technical Knowledge: Comprehensive understanding of global regulatory procedures for studying new veterinary medicinal products, along with a broad knowledge of license procurement across various geographies (preferable).
• Risk & Decision Making: Strong grasp of risk assessment and risk management fundamentals/tools. Ability to make sound decisions even when there is no clear right or wrong answer.
• Business Partnering & Influence: Demonstrated effectiveness in business partnering across the enterprise, functions, and with external stakeholders. Strong interpersonal and communication skills, with the ability to influence and diplomatically challenge when necessary.
• Operational Management: Ability to align resources with company objectives and facilitate accurate, timely project and budget forecasts.
• Personal Leadership: Demonstrated courage in navigating difficult situations.
• What will give you a competitive edge (preferred qualifications):
• Knowledge of Continuous Improvement Six Sigma and Lean Principles
• Experience of working with novel regulatory pathways/mechanisms would be advantageous.
• Additio

Benefits

Additional Information

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: Global Regulatory Project Lead - Global Regulatory Affairs This role leads and oversees regulatory activities for pre-approval and life cycle management, collaborating with key stakeholders (Global R&D, Sales & Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services). As the Global Regulatory Project Lead, you are accountable for the innovation project regulatory strategy in all key first-wave countries, working directly with the development team. You are responsible for leading regulatory processes for the EU/USA and will work across the broader organization to ensure submissions and approvals in other first-wave countries follow the global regulatory strategy.

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