Regulatory Affairs Manager Iberia

• 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. 

• Travel: 0-20%
• Location: ES - Madrid
  

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

• →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