Regulatory Affairs Manager Iberia

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: Regulatory Affairs Manager Iberia

 Your Responsibilities:


* Responsibility for Agency relations by maintaining close contacts to the relevant authorities.

Responsible for thorough understanding of local requirements and in the turntable function s/he has general understanding and knowledge of regulatory requirements for all countries supported.

Competent authority interactions may range from written communications to in-person meetings within the scope of responsibility. 


* Responsibility for ensuring professional planning, competent RA input, efficient registration and maintenance of the registrations of existing marketing authorizations in accordance with business needs, directions and strategies.

S/he plans, directs and coordinates all regulatory activities of the assigned products or areas of responsibility. 


* Ensures regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submissions and strict participation in the global/local change control operations.

Ensures regulatory compliance by timely submission of variations. 


* Ensures compliance to procedures and systems necessary to maintain proper regulatory records. 


* Ensure regulatory compliance to product labels, promotional materials and local pharmacovigilance. 


* Performs other related duties and assignment as required by the business and directed by management. 


* Advises business and provides guidance/direction on regulatory matters, making recommendations and giving direction considering current and future trends. 


* May participate and represents RA and EAH in various teams, trade associations and professional organizations in close collaboration with Market Access. 


* Ensures clinical trial applications and import permits and supports innovation team 

 

 What You Need to Succeed (minimum qualifications):



* Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent. 


* Fluent spoken and written English, Spanish and/or Portuguese essential. 

 

 What will give you a co...