Global Regulatory Project Lead - Global Regulatory Affairs

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.
 

Your 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.


* Agency Engagement & Relationships: Lead engagements with regulatory agencies in the EU/USA and facilitate efficient interactions with Health Authorities (HA) in collaboration with regional leaders.

Develop and maintain effective relationships with global regulatory authorities and participate in industry associations.


* 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: Lea...