Associate/Sr Associate/ Manager/Sr Manager/, GRA-EMEA Regional Regulatory Clinical Trial Submission Lead

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

PURPOSE

Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Clinical Trial Submissions Lead, in partnership with the GRA-EMEA Regional Regulatory Scientist (RRS), is accountable to establish the local regulatory strategy and plan for assigned clinical trials across the region, with a primary focus on the European Union. The GRA-EMEA Clinical Trial Submissions Lead provides regional regulatory expertise in supporting the delivery of high quality and efficient regulatory clinical trial submissions, regulatory responses and approvals in compliance with local regulations.

Primary Responsibilities:

Clinical Trial Applications

• Create and drive submission strategy plan for the region in partnership with GRA-EMEA RRS, Trial Capabilities (TC) and Project team. Advise on optimum submission pathway to accelerate clinical trials approvals in the region.
• Co-ordinate and lead the Clinical Trial Application (CTA) Kick-Off Meeting.
• Prepare and review submission documents in accordance with local requirements and ensure accuracy of submission package to minimise any errors before submissions. Support interactions with regulatory agencies in partnership with the GRA-EMEA RRS.
• Support high quality regulatory responses in partnership with appropriate team members.
• Communicate key milestones to the Project team, including tracking and documentation in appropriate systems.
• Ensure coordination with Third Party Operations.

Modifications/ Trial Maintenance

• Play an active role in strategic decisions around submission of modifications in partnership with TC and the Project team.
• Prepare & review submission documents in accordance with local requirements and ensure accuracy of submission package to minimise any errors before submissions.
• Support high quality regulatory responses in partnership with appropriate team members.
• Communicate key milestones to the Project team, including tracking and documentation in appropriate systems.

Regulatory Expertise for Clinical Trials in the Region

• Provide up-to-date expertise on clinical trial regulations and guidelines.
• Ensure compliance with all applicable regulations and internal quality systems.
• Interpret and anticipate impact of new guidelines and work with GRA-EMEA RRS to initiate change in response to changing environment.
• Identify and communicate internal and external trends. Incorporate these insights into internal strategies.

Lead, influence and partner

• Partner with the GRA-EMEA RRS to help solve development and regulatory issues impacting clinical trials.
• Participate in forums that share clinical trial information & expertise across GRA and other Lilly teams and business partners.
• Propose and lead continuous improvement projects to simplify clinical trial processes and increase efficiencies.
• Represent the regulatory function on cross-functional clinical trial-related projects.

• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
• Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Constructively challenge teams to reach the best solutions to issues.
• Create and lead in an environment of equity and inclusion that encourages open discussions on issues to achieve a robust outcome on business decisions.

Minimum Qualification Requirements:  

• Bachelor’s degree in scientific or health sciences discipline
• Fluency in English
• Ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes
• Ability to assess and propose ways to manage risk in a highly regulated environment
• Demonstrated strong written, spoken and presentation communication skills
• Demonstrated negotiation and influence skills

• Demonstrated attention to detail
• Demonstrated proactivity & strong organisational skills

• Demonstrated ability to effectively work independently and in a team
• Knowledge of the drug development process
• Industry-related or other relevant work experience of 1-3 years

Other Information/Additional Preferences:  

• Knowledge of local/regional regulatory procedures and practices, particularly related to EU clinical trial applications.
• Previous Regulatory Affairs experience.

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.

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