Lilly Regulatory Associate in United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.
We have a fantastic opportunity for a regulatory scientist to join the Regulatory Affairs team in our shiny, brand new site in Bracknell.
To prepare clinical trial applications, variations and other submissions for European and International markets,
Establish and maintain contacts with development project/program team members
Provide quality regulatory input to non-product related activities
Implement aspects of the regulatory plan.
Establish and maintain quality files in accordance with internal procedures.
Establish and maintain status reports
Liaise with the affiliates to anticipate country specific issues such as impact of the clinical plan and Summary of Product Characteristics (SmPC) on promotion, in pricing and reimbursement.
Keep regulatory representatives in the affiliates up to date on relevant submission issues
Develop expertise on European registration submissions and relevant guidelines.
Minimum Qualification Requirements:
- Technical Knowledge:
Computer skills (Word, Excel, Power Point)
Understanding of the cross functional nature of drug development and regulatory implications
- Influence/Interpersonal Skills:
Ability to get on well with people
Familiarity and openness towards cultural diversity.
Embraces different styles of working
- Self Management:
Ability to work independently and in teams
Time management skills
Willingness to learn and continue learning
Ability to share experiences and learning points
Good communication skills: presenting and listening
Provision of clear written documents
Problem solving skills
Proposes ideas to enhance regulatory output
Graduate or PhD qualification in science, pharmacy or medicine
A few years' relevant Regulatory experience
Knowledge of two European languages or an European and another language
Use of databases relevant to regulatory business
Sound like you? Apply now to be a part of our high performing and diverse team. In return, we’ll give you the opportunity to thrive in the role while bringing your authentic self to work.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!