Senior Regulatory Associate/Manager - Global Regulatory Affairs, International
Bracknell, United Kingdom
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 35,000 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’s International Regulatory Affairs team are laser focused on providing world class regulatory support to a variety of programs across the therapeutic spectrum. This team, made up of thought leaders, technical specialists and strategic experts have been responsible for the creation and submission of high-quality dossiers to regulatory bodies across the International Business Unit. By joining the team as a Senior Regulatory Associate, you will be working in a role which has impact and provides opportunities to learn from well respected industry figures.
The purpose of the Senior Regulatory Associate role is to represent International Business Unit (IBU) on one or more programs in a therapeutic area. It is anticipated that at least 70% of the role will focus on critical EU markets. The Senior Regulatory Associate will ensure compliance with all applicable regulations and internal quality systems while also supporting senior scientists on product teams.
This position will be responsible for providing solicited and unsolicited advice to program team members to ensure appropriate labelling, regulatory strategy, and a timely, high quality EU dossier. You will also ensure the unique dossier requirements of the countries in the IBU (other than EU) are considered and that high quality dossiers for all the IBU markets are delivered.
In this position you will provide support to develop and execute a robust regulatory and submission sequencing strategy for the countries in the IBU (other than EU). This will also include maintaining licenses after approval and supporting clinical trial applications in European and other IBU Markets countries.
- Liaise with the affiliates to anticipate country specific issues, impact of the clinical plan and Summary of Product Characteristics (SmPC) on promotion, in pricing and reimbursement. Be an efficient liaison between the affiliates and corporate (product team, GRA-CMC (Chemistry, Manufacturing and Control))
- Keep regulatory representatives in the affiliates up to date on relevant submission issues
- Develop deep expertise on European registration procedures, relevant guidelines and competition
- Develop expertise in specific regulatory area as agreed (become an expert)
- Establish and maintain quality files in accordance with internal procedures
- Establish and maintain contacts with other project/program team members
- Bring IBU drivers and perspectives to team meetings
- Lead small submissions, create, write and evaluate regulatory documents
- Support clinical trial applications in European and other IBU countries (if applicable) - help define the Core Label
- Prepare section for regulatory plan, including high level regulatory strategy for first submission, line extensions, secondary indications, etc.
- Implement aspects of the regulatory plan
- With management help, influence the regulatory agencies, industry associations in favor of the planned development
- Support appropriate interactions with agencies for scientific advice and resolves issues during review phase
- May serve as global regulatory co-ordinator on a program team
- Participate in IBU meetings to ensure that regulatory strategy and issues are taken into account and to learn about their needs
Minimum Qualification Requirements:
- Computer skills (Word, Excel, Power Point)
- Understanding of the cross functional nature of drug development and regulatory implications.
- Ability to get on well with others
- Familiarity and openness towards cultural diversity. Embraces different styles of working
- 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
- Understanding and knowledge of medicines
- Knowledge of two European languages or a European and another IBU country language
- Graduate qualification in a relevant subject: pharmacy, medicine, science
- Relevant work experience
- Use of databases relevant to regulatory business
- Key Contacts: Program team members, regional marketing/medical, affiliate regulatory representatives Job Description Version History:
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 met 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.
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 ( Lilly_Recruiting_Compliance@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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-34438.
Lilly 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.
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