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- Tasks: Lead regulatory strategy and submissions for life-changing medicines in the EMEA region.
- Company: Join Lilly, a global healthcare leader dedicated to improving lives through innovative medicines.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on global health while working in a collaborative and inclusive environment.
- Qualifications: Advanced scientific degree or significant experience in regulatory affairs and drug development required.
- Other info: Be part of a team that values diversity, equity, and inclusion in all interactions.
The predicted salary is between 72000 - 108000 £ per year.
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 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.
Location: Hybrid in an affiliate office
Purpose: The Senior Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy and ensure local regulations and region/country business needs are included. The Senior Director/Executive Director is responsible for leading meetings and other interactions with region/country regulators. The Senior Director/Executive Director performs regulatory evaluations of external business opportunities, as requested by management, and effectively manages alliance/CRO relationships in the regulatory area.
Primary Responsibilities:
- Provide region/country input and review of global strategic plans and global/regional submission plan and documents.
- Contribute during key governance committees on regional regulatory strategy decisions, if requested.
- Ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners in contributing to development of submission content.
- Own relationship and lead meetings and interactions with regulators in assigned region.
- Influence the regulator in favour of the planned development.
- Lead development of local/regional labelling strategy and network for alignment across region/affiliate team.
- Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content.
- Lead team during negotiation with regulators by providing responses to labeling questions.
- Ensure compliance with all applicable regulations and internal quality systems.
- Provide up-to-date expertise on regional registration procedures.
- Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
- Own all regulatory activities in support of assigned marketed product(s) in the region/country.
- Be involved in medical device/in-vitro diagnostics regulatory activities.
- Ensure the registration needs for local patients in clinical trials are met for countries in the region/country.
- Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations.
- Liaise with the affiliates to anticipate region/country specific issues.
- Participate in regional meetings to ensure that regulatory strategy and issues are considered.
- Propose continuous improvement projects to simplify processes and increase productivity.
- Lead or represent the regulatory function on cross-functional non-product related projects.
- Serve as a mentor for GRA personnel.
- Exemplify Team Lilly behaviours: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
Minimum Qualification Requirements:
- Advanced scientific degree (i.e., PhD, MD, PharmD) or bachelor’s with significant relevant industry-related experience in regulatory affairs and/or drug development.
- Industry-related experience in regulatory affairs and/or drug development experience.
- Knowledge of local/regional regulatory procedures and practices.
- Aware of evolving regulatory reform initiatives, preferred.
- Demonstrated knowledge of the integrated drug development process and regulatory/business strategies.
- Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion.
- Demonstrated ability to assess and manage risk in a highly regulated environment.
- Strong written, spoken, and presentation communication skills.
- Demonstrated negotiation and influence skills.
- Demonstrated attention to detail.
Contact Detail:
Eli Lilly and Company Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director, Global Regulatory Affairs-EMEA
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in EMEA regulations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with Lilly's values and mission. Understanding how they unite caring with discovery can help you align your experiences and aspirations with their goals during interviews and discussions.
✨Tip Number 3
Prepare for potential interviews by reviewing common regulatory scenarios and case studies relevant to the EMEA region. Being able to discuss specific examples of how you've navigated regulatory challenges will demonstrate your expertise.
✨Tip Number 4
Stay updated on recent changes in regulatory policies within the EMEA region. This knowledge will not only enhance your discussions with regulators but also show your commitment to staying informed in a rapidly evolving field.
We think you need these skills to ace Senior Director, Global Regulatory Affairs-EMEA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs and drug development. Emphasise your leadership roles and any specific achievements that align with the responsibilities of the Senior Director position.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving lives through healthcare. Discuss how your background and skills make you a perfect fit for Lilly's mission and the specific requirements of the role.
Showcase Your Communication Skills: Given the importance of communication in this role, provide examples in your application that demonstrate your strong written and spoken communication skills, particularly in regulatory contexts.
Highlight Team Leadership Experience: Since the role involves leading teams and mentoring others, include specific instances where you've successfully led projects or teams, especially in a regulatory environment, to showcase your leadership capabilities.
How to prepare for a job interview at Eli Lilly and Company
✨Understand the Regulatory Landscape
Familiarise yourself with the local and regional regulatory procedures relevant to the role. Be prepared to discuss how these regulations impact drug development and approval processes, as well as any recent changes in legislation that could affect the company.
✨Showcase Your Leadership Skills
As a Senior Director, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've successfully led teams or projects in the past, particularly in high-pressure situations involving regulatory submissions or negotiations with regulators.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in regulatory affairs and how you navigated them, especially those that required collaboration with cross-functional teams.
✨Emphasise Communication and Negotiation Skills
Effective communication is key in this role. Be ready to discuss your experience in presenting complex regulatory information to diverse audiences and how you've influenced stakeholders or regulators in favour of your proposals.
