Associate/Sr. Associate - Clinical Regulatory Scientist

We’re looking for people who are determined to make life better for people around the world.Associate, Clinical Regulatory Scientist - CorkJob DescriptionAt Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. Path/Level: P1/P2/P3Note: Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities. Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role. The purpose of the Regulatory Scientist, GRA-NA GBS Centre role is to provide tactical and operational direction and support to deliver US and Canada regulatory strategies and to expedite the development and delivery of safe and effective products to patients. The Regulatory Scientist partners across Lilly teams, partner companies, and health authorities to enable market differentiation of first-in-class/best-in-class assets.Primary Responsibilities:Regulatory and Scientific Expertise1. Develop, Update and Execute US and Canada Registration StrategyAssist the P4/P5 Regulatory Scientist in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/Health Canada meetings and regulatory trends. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies.Review and summarize, information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.Monitor upcoming and recent approvals of competitive programsCommunicate and share key information to enable seamless execution of US/Canada regulatory strategy2. Provide input to clinical program to support market differentiation needsCommunicate the regulatory options and impact on proposed product development plans, seeking P4/P5 Regulatory Scientist and management alignment.Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation.3. Develop and Update US and CA labelling, including prescribing information, patient labelling, device labelling (IFU) for new products and indicationsSupport 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 in collaboration with P4/P5 Regulatory Scientist. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling.Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.4. Support development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novoDetermine and communicate submission and approval requirements and regulator expectationsAssist P4/P5 Regulatory Scientist to 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 the MDU function 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.5. Liaison with late lifecycle/legacy product teamProvide high quality, timely and decisive regulatory advice, in collaboration with the P4/P5 Regulatory Scientist, that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory managementCultivate relationships with development teams.6. Support relationship and interaction strategy with US and Canada regulatory authoritiesBuild, maintain, and leverage relationships with 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 in partnership with P4/P5 Regulatory Scientist.Support communications to the regulator, development teams, and GRA, MDU, Research, and BU leadership.Lead/Influence/PartnerExemplify Team Lilly behaviours: Include, Innovate, Accelerate, Deliver in internal and external interactionsModel the innovation and leadership behaviours 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 partnersConstructively challenge teams to reach the best solutions to issuesCreate and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisionsMinimum Qualification Requirements:Bachelor’s degree in scientific or health sciences disciplinePreferred industry-related experience in regulatory affairs and/or drug development experience for 2 yearsKnowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirableDemonstrated deep knowledge of the drug development process, Lilly regulatory/business strategies and plans requiredDemonstrated ability to assess and manage risk in a highly regulated environmentDemonstrated strong written, spoken and presentation communicationDemonstrated negotiation and influence skillsDemonstrated attention to detailDemonstrated effective teamwork skills; able to adapt to diverse interpersonal stylesOther Information/Additional Preferences:Travel expected (less than 10%)Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.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.#WeAreLillyLilly 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.#WeAreLilly