Global Regulatory Project Lead - Global Regulatory Affairs in Hook

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 including Global R&D, Sales & Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services.

Your Responsibilities

• Strategy & Technical Leadership: Lead the design and development of regulatory strategies and technical documentation, ensuring timely compliance and success of global development projects.
• Agency Engagement & Relationships: Lead engagements with regulatory agencies in the EU/USA and facilitate efficient interactions with Health Authorities, develop and maintain global regulatory relationships, and participate in industry associations.
• Project Oversight & Risk Management: Manage and prioritize resources to meet project timelines, proactively identify and communicate risks, opportunities, and impacts to internal stakeholders.
• Cross-Financial Collaboration: Represent the regulatory viewpoint on development and governance teams, provide insight into product development, target labels, and registration, and influence strategies through collaboration with R&D, Global Marketing, Legal, and Manufacturing & Quality.
• Clinical & Quality Compliance: Enable the development of clinical trial submission plans, review project-related communications, and generate and review policies, SOPs, and guidance to ensure compliance.
• Meeting Leadership: Lead team meetings regarding Quality, Safety, and Effectiveness technical sections during regulatory agency interactions, or support team members as needed.
• Policy & Ethics: Comply with all company local and global policies, including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and HSE standards.

Minimum Qualifications

• Education: Master’s degree or higher in Veterinary Medicine, Biology, Infectious Diseases, Immunology, or a related field.
• Experience: Minimum 10 years of animal health industry experience with direct Regulatory Affairs expertise on Pharmaceutical, Biological, and/or Nutritional products, including regulatory affiliate operations and quality/operational areas.
• Technical Knowledge: Comprehensive understanding of global regulatory procedures for new veterinary medicinal products and a broad knowledge of license procurement across various geographies.
• Risk & Decision Making: Strong grasp of risk assessment and risk management tools and the ability to make sound decisions in ambiguous situations.
• Business Partnering & Influence: Ability to partner across functions and external stakeholders, with strong interpersonal and communication skills.
• Operational Management: Ability to align resources with company objectives and forecast projects and budgets accurately.
• Personal Leadership: Demonstrated courage in navigating difficult situations.

Preferred Qualifications

• Knowledge of Continuous Improvement, Six Sigma, and Lean Principles.
• Experience with novel regulatory pathways or mechanisms.

Additional Information

• Travel: 0-10%
• Location: DE – Monheim or BE – Antwerp or UK – Hook – Hybrid Work Environment

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.

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