Senior Regulatory Affairs Manager

1w1 week ago

Elanco

Hook, GB · Full-time · £80,000 – £110,000

About this role

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. 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.

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. You will advance the regulatory strategy for innovation projects across key countries. This involves working collaboratively with Global R&D, Sales and Marketing, Supply Chain, and other key stakeholders.

Elanco prides itself on fostering a diverse and inclusive work environment that values new ways of thinking. You’ll work with dynamic individuals in a company that champions diversity as the driving force behind innovation, creativity, and business success. Making animals’ lives better makes life better – join our team today!

Acquire new skills and experiences that will propel your career to new heights. Don’t meet every single requirement? Studies show underrecognized groups are less likely to apply unless they meet every qualification – we encourage you to apply if you think you might be a good fit.

Requirements

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.
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.

Responsibilities

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.