Associate Director - Clinical Regulatory Scientist (Specialising in Pediatrics) Locations: Ireland, Cork
Time Type: Full time
Posted on: Posted 3 Days Ago
Job Requisition ID: R-71384
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 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 put people first and are looking for individuals who are determined to make life better for patients globally.
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 we also develop creative solutions to support communities through philanthropy and volunteerism.
Primary Responsibilities: Regulatory and Scientific Expertise Develop, Update and Execute US and Canada Registration Strategy Initiate and Update Regulatory Strategy Document Assist or lead in the development of regulatory strategy by leveraging scientific knowledge from FDA/HC meetings and regulatory trends. Review, summarize, and present information regarding regulator expectations. 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 for seamless execution of US/Canada regulatory strategy. Provide input to clinical program to support market differentiation needs Communicate regulatory options and impact on proposed product development plans. Leverage innovative regulatory strategies to accelerate asset development. Collaborate with PRA and VEO for pricing and access strategies. Support development and update of labeling strategy Initiate and update Claims Mapping and Labeling Dashboard. Partner with regulatory and clinical development teams to drive Market Differentiation. Create and communicate labeling dashboard for internal alignment. Develop and Update US and CA labeling Support the development of US/Canadian labeling strategy. Support strategic development of US/CA labeling documents. Support development of strategy for submission and amendments Determine and communicate submission and approval requirements. Generate regulatory documents for submissions. Anticipate and resolve key technical and operational issues. Liaison with product and clinical development teams Provide high-quality regulatory advice. Communicate regulatory risks and mitigation plans. Cultivate relationships with development teams. Liaison with global marketing/NPP/VEO/Payer functions Contribute to global and US launch-readiness plans. Cultivate relationships with global marketing functions. Own relationship and interaction strategy with US and Canada regulatory authorities Build and leverage relationships with FDA and Health Canada. Execute high-quality communications with regulators. Advise/Approve US promotional strategy and claims Set direction with Global Marketing for promotional claims development. Partner with Regulatory Ad/Promo reviewer for approvals. Lead/Influence/Partner Exemplify Team Lilly behaviors in interactions. Participate in forums sharing regulatory information. Create an environment encouraging open discussions. Minimum Qualification Requirements: Bachelor's degree in scientific or health sciences discipline. 5-8 years of industry-related experience in regulatory affairs and/or drug development. Knowledge of FDA and Health Canada procedures and practices. Other Information/Additional Preferences: Deep knowledge of the drug development process. Ability to assess and manage risk in a regulated environment. Strong written, spoken, and presentation communication skills. Demonstrated negotiation and influence skills. Attention to detail. Effective teamwork skills; able to adapt to diverse interpersonal styles. Travel expected (10-15%). Lilly is dedicated to helping individuals with disabilities engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance.
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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