Especialista en Asuntos Regulatorios

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Responsibilities

• Manage the preparation, submission and maintenance of marketing authorisations for products registered under the Mutual Recognition, Decentralised and Centralised procedures.
• Smooth and ongoing interaction with the health authorities.
• Creation and review of medicinal product packaging materials.
• Coordination with the various company departments involved.
• Use and maintenance of regulatory databases.
• Implementation of effective regulatory strategies and monitoring of these.
• Close interaction and collaboration with various departments within the company at both local and European levels.
• Management and implementation of regulatory procedures and internal policies.
• Thorough knowledge of applicable legislation in the field of registration. Continuous review of new European and local legislation. Analysis of such legislation.
• Participation as a member of professional technical associations.

Minimum requirements

• Bachelor’s degree in Health Sciences
• Specialised training in European procedures for the registration and regulation of medicinal products
• 5 years’ experience in a pharmaceutical company or at the AEMPS
• High level of English (C1-Advanced or equivalent)

Additional Information

The ideal candidate will be proactive, with excellent communication skills, the ability to solve problems and work as part of a team, and a strong sense of organisation and attention to detail.

Actual remuneration will depend on the candidate’s education, experience, skills and geographical location. The salary range for this role is: 40,478.00 – 67,463.00

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.