Lead the design and development of regulatory strategy and technical documents in support of global development projects.
Manage resources and provide technical leadership to ensure timely delivery of regulatory activities and compliance.
Represent the regulatory viewpoint on development teams and lead engagements with regulatory agencies in the EU or the USA.
Develop and maintain effective relationships with global regulatory authorities and influence industry associations.
Proactively identify and communicate project-specific risks and opportunities to internal stakeholders.
What You Need to Succeed (minimum qualifications):
Master's degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
A minimum of 10 years of experience in the animal health industry, with direct Regulatory Affairs experience with biologics/large molecule products.
Demonstrated regulatory leadership and dossier registration experience, alongside a strong understanding of global regulatory procedures and risk assessment fundamentals.
What will give you a competitive edge (preferred qualifications):
Master's degree in Life Sciences or Management.
Broad knowledge covering obtaining licenses in different geographies.
Experience working with novel regulatory pathways or mechanisms.
Strong interpersonal and communication skills with the ability to influence and diplomatically challenge.
Fluent in English.
Additional Information:
Travel: 10-25% annually
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
Benefits
Health insuranceVision insurance
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: Senior Regulatory Affairs Manager
As a Senior Regulatory Affairs Manager, you will be part of the global regulatory team to deliver pre-approval and life cycle management for development projects. In this role, you will be responsible for advancing the regulatory strategy for innovation projects across key countries, working collaboratively with Global R&D, Sales and Marketing, Supply Chain, and other key stakeholders.
Elanco · United Kingdom