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Regulatory Expert for Global Affairs

2 mesi fa

Roma, Lazio, Italia Eli Lilly and Company A tempo pieno
  • At Eli Lilly and Company, we unite vision with innovation to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.
  • We are seeking a talented Regulatory Expert to join our team in Global Affairs, who will be responsible for establishing local regulatory strategies and plans for assigned products in the region/country.
  • Our ideal candidate will have a strong background in regulatory affairs and a proven track record of delivering high-quality regulatory submissions, approvals, and local labeling for their assigned products.
  • Responsibilities include providing regional regulatory expertise in delivering regulatory submissions, approvals, and local labeling for their assigned products, leading meetings and other interactions with region/country regulators, and performing regulatory evaluations of external business opportunities.
  • As a key member of our team, the successful candidate will contribute to the development of submission content, engage cross-functional partners, and ensure compliance with all applicable regulations and internal quality systems.
  • The ideal candidate will have a minimum of 5 years of industry-related experience in regulatory affairs and/or drug development, knowledge of local/regional regulatory procedures and practices, and awareness of evolving regulatory reform initiatives.
  • We value diversity and inclusion at our company, and we are committed to creating a workplace where everyone feels welcome and valued.

Primary Responsibilities:

  • Providing Regulatory Expertise for Assigned Program/Product(s) in Region/Country
  • Region/country input and review of global strategic plans and global/regional submission plan and documents
  • Contribute during key governance committees on regional regulatory strategy decisions, if requested
  • Ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners in contributing to development of submission content
  • Own relationship and lead meetings and interactions with regulators in assigned region and engage cross-functional partners to contribute to regulator interactions
  • Influence the regulator in favor of the planned development
  • Lead development of local/regional labeling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones
  • Apply labeling expertise, competitor knowledge, and regulatory precedent to propose labeling content to influence commercially viable labeling in region/country
  • Lead team during negotiation with regulators by providing responses to labeling questions
  • Ensure compliance with all applicable regulations and internal quality systems
  • Provide up-to-date expertise on regional registration procedures
  • Interpret and anticipate impact of new guidelines and initiate change in response to changing environment
  • Own all regulatory activities in support of assigned marketed product(s) in the region/country