Regulatory Affairs Manager Iberia

elanco; España; On-site; EUR 70,000 - 90,000; Full time

Job summary

Elanco seeks a Regulatory Affairs Manager Iberia in Madrid to lead regulatory activities for our animal health products. You will coordinate submissions, maintain registrations, and ensure compliance with local and global requirements.

The role involves collaboration with cross-functional teams and interactions with authorities. The ideal candidate has an advanced life sciences degree, fluent English and Spanish (Portuguese optional), and 2+ years in regulatory affairs, preferably in animal

Qualifications

• Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry).
• Fluent spoken and written English, Spanish and/or Portuguese essential.

Responsibilities

• Manage regulatory activities for assigned products or areas of responsibility.
• Ensure timely submissions and regulatory compliance with local and global requirements.
• Interact with authorities and support labeling, variations, and pharmacovigilance activities.

Skills

English

Spanish

Portuguese

Education

Advanced degree in life sciences

Tools

MS Word

MS Excel

Job description

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!

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. 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 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; the ability to work autonomously; an awareness of global needs/requirements.
• Experience with developing and building talent.
• Knowledge of PC package tools, including (e.g.), Word and Excel required; knowledge of data management systems.
• Ability to set priorities, manage multiple tasks, identify solutions to problems/pre-emptive behavior. Ability to evaluate and assess risk.

Travel: 0-20% Location: ES - Madrid

Additional Information

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.