Associate -R&D

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!

Job Description:

The purpose of Associate Manager/Manager/Senior Manager - Regulatory, is to work cross functionally with Elanco R&D groups, Manufacturing and Quality to develop the global regulatory strategy, oversee submission preparation and meet the reporting requirements for the Authorization and Maintenance of registrations of new animal drugs with global regulatory agencies.

Demonstrated knowledge of the drug development process and regulatory submissions with expertise in end-to-end life cycle management (LCM) of a multitude of complex pharmaceutical dosage forms.

Design/develop regulatory strategy for geo-expansion of marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.

Maintain a positive collaboration and partnership with internal groups in R&D, Quality, Manufacturing and with global regulatory business partners of Elanco.

Contribute to pre-submission preparation and proactively communicate regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams, while applying the global strategy into submissions.

Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked according to the functional procedures

Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends.

Minimum Qualification (education, experience and/or training, required certifications):

Degree in Science (BSc; MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)

Minimum Experience:

5+ years in Global Regulatory Affairs

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