Job title: Associate Manager / Manager – Regulatory Scientist

Company: Eli Lilly

Job description: 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 sp

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. Regulatory and Scientific Expertise Develop, Update and Execute US and Canada Registration Strategy Assist 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 programs 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 P4/P5 Regulatory Scientist and management alignment. Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation. Develop and Update US and CA labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications 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 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. 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 Assist 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. Liaison with late lifecycle/legacy product team Provide 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 management Cultivate relationships with development teams. Support relationship and interaction strategy with US and Canada regulatory authorities Build, 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/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: Master’s degree in scientific or health sciences discipline Industry-related experience in regulatory affairs and/or drug development experience for 5-7 years Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable 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 Demonstrated negotiation and influence skills Demonstrated attention to detail Demonstrated effective teamwork skills able to adapt to diverse interpersonal styles Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively ‘Lilly’) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [HIDDEN TEXT] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. #WeAreLilly

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 29 Jun 2022 22:00:54 GMT

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