Associate Director - Clinical Regulatory Scientist

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.
At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. Our 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 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.
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.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory and Scientific Expertise Develop, Update and Execute US and Canada Registration Strategy Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends.Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.Monitor upcoming and recent approvals of competitive development programs/plans.Integrate US/CA regulatory strategy into global registration strategy.Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy.Communicate and share key information to enable seamless execution of US/Canada regulatory strategy.Provide input to clinical program to support market differentiation needs Communicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment.Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.Support development and update of labeling strategy to deliver market differentiation Initiate and update Claims Mapping, and Labeling Dashboard Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping) and network for alignment.Create and communicate labeling dashboard to drive internal alignment on labeling strategy and key risks.Develop and Update US and CA labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications Support the development of the US/Canadian labelling strategy in collaboration with Senior Regulatory Scientist and project personnel.Support strategic development of US/CA labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions.Support development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo Determine and communicate submission and approval requirements and regulator expectations.Generate regulatory documents for submissions. Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly's scientific position.Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team.Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.Liaison with product and clinical development team and liaison with diagnostic development experts Provide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning.Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management.Cultivate relationships with development teams.Liaison with global marketing/NPP/VEO/Payer functions/US Brand Teams Contribute to global and US launch-readiness plan and connect commercial partners with development teams to drive market differentiation strategy for assigned assets, including labelling and promotional deliverables throughout the product lifecycle.Cultivate relationships with global marketing/NPP/VEO/Payer functions/US Brand Teams.Own relationship and interaction strategy with US and Canada regulatory authorities Build, maintain, and leverage relationships with FDA, Health Canada, team members, and partner companies as appropriate.Execute high quality communications with FDA, Health Canada, and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues.Accountable for communications to the regulator, development teams, and GRA, other development functions, Research, and BU leadership.Advise/Approve US promotional strategy and claims Review corporate communications press releases and social media posts Set appropriate direction with Global Marketing and US Brand Team for development, review and approval of promotional claims.Partner with Regulatory Ad/Promo reviewer to advise US Brand Team on promotional strategy.Partner with Regulatory Ad/Promo reviewer to review and approve press materials and IR communications.Lead/Influence/Partner Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.Model the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.Constructively challenge teams to reach the best solutions to issues.Create and lead in an environment 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.Industry-related experience in regulatory affairs and/or drug development experience for minimum of 2 years.Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable.Other Information/Additional Preferences: Demonstrated deep knowledge of the drug development process, Lilly regulatory/business strategies and plans required.Demonstrated ability to assess and 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 effective teamwork skills; able to adapt to diverse interpersonal styles.Travel expected (10-15%).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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