Regulatory Affairs Manager Iberia (La Mancha)

Regulatory Affairs Manager Iberia (La Mancha)

23 oct
|
Elanco
|
La Mancha

23 oct

Elanco

La Mancha

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. 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 Regulatory Affairs Manager Iberia 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. 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. 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. Fluent spoken and written English, Spanish and/or Portuguese essential. What will give you a competitive edge (preferred qualifications) Minimum 2 years of experience in regulatory affairs, preferably animal health, combined with knowledge in product development or equivalent relevant experience. Experienced project team member with demonstrated communication skills both verbal and written; an awareness of general needs/requirements. Word and Excel required; knowledge of data management systems. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

📌 Regulatory Affairs Manager Iberia (La Mancha)
🏢 Elanco
📍 La Mancha

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