Regulatory Affairs Specialist

Hybrid in Alcobendas·Full-time·Added 3 days ago

Eli Lilly

10 open roles

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Overview

Job details

€40,478 - €59,368 a year
Gross, as stated in the ad.
About €2,500 - €3,420 a month after tax.
Full-time hours
Per the ad.
Hybrid
Office and home days — the ad has the split.

Requirements

Have the right to work in Spain
Eli Lilly doesn't mention sponsorship in the ad.
Work in English
English is required, per the ad.
Be near Alcobendas for hybrid days
No relocation package mentioned.
Have 5+ years of experience
Mid-level role.
University degree
“Bachelor's degree in Health Sciences” — per the ad.

Pay & benefits

What you'll get

Actual remuneration will depend on the candidate's education, experience, skills and geographical location. The salary range for this role is: 40,478.00 - 59.368,00 Eur.

Requirements

What we're looking for

Bachelor's degree in Health Sciences
5 years' experience in a pharmaceutical company or at the AEMPS
High level of English (C1-Advanced or equivalent)

Nice to have

Specialised training in European procedures for the registration and regulation of medicinal products

The role

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.

What you'll do

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.

About Eli Lilly

Eli Lilly and Company is a global pharmaceutical corporation headquartered in Indianapolis, USA, with a strong focus on discovering and developing life-changing medicines. The company is a major player in areas such as diabetes, oncology, immunology, and neuroscience, and is known for its significant investment in research and development. With a workforce of over 40,000 employees worldwide, Eli Lilly operates in numerous countries, bringing innovative treatments to patients across the globe.

In Spain, Eli Lilly has a substantial presence, with offices in Madrid and a major manufacturing and packaging plant in Alcobendas. The company is committed to the Spanish market, contributing to local healthcare and offering a range of opportunities in quality assurance, engineering, production, and clinical research. For international professionals, Eli Lilly in Spain offers a dynamic work environment that values innovation and collaboration, with roles that often require a blend of local and global expertise.

Industry: Pharma
Founded: 1876
Employees: 10,000+
Headquarters: Indianapolis, USA
In Spain: Madrid, Alcobias
Website: lilly.es

Good to know if you are moving

Eli Lilly has a significant manufacturing and packaging plant in Alcobias, Spain, which is a key site for its European operations.
The company offers a range of roles in Spain, from quality assurance and engineering to production and clinical research, providing diverse opportunities for international professionals.
Eli Lilly is known for its strong commitment to research and development, offering a stimulating environment for those interested in pharmaceutical innovation.
The company has a global presence, which can facilitate international career mobility and collaboration across different regions.
Working in Spain for Eli Lilly may involve interacting with a multicultural team, given the company's international footprint.

In their own words

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.

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

4 - 4

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.

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