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Eli Lilly and Company
Eli Lilly and Company
Asistență medicalăBiotehnologieProduse farmaceutice
Eli Lilly and Company este o companie multinațională farmaceutică și de asistență medicală, axată pe descoperirea, dezvoltarea, fabricarea și comercializarea medicamentelor eliberate pe bază de prescripție medicală. Activitatea sa acoperă domenii terapeutice precum diabetul, oncologia, imunologia, neuroștiința și durerea, combinând cercetarea și dezvoltarea cu studiile clinice, procesele de reglementare, producția de medicamente biologice și cu molecule mici, precum și distribuția globală.
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Senior Global Regulatory Lead, Neuroscience – Eli Lilly, Indianapolis

Lead global regulatory strategy for Lilly’s neuroscience medicines throughout development and across their full lifecycle. Oversee FDA submissions and agency engagement while guiding cross-functional regulatory teams.

USStatele Unite ale Americii
175.500 $ – 257.400 $ / an
La sediuNormă întreagăSeniorLimbă Obligatorie: englezăConformitate

Descriere

  • Own and advance global regulatory strategies and the Regulatory Strategy Document from candidate selection through the end of the product lifecycle.
  • Use competitive intelligence, health authority guidance, and product-specific advice to shape robust, forward-looking regulatory strategies.
  • Represent regulatory affairs on the GBD and global program team, influence development plans, and resolve regulatory obstacles.
  • Align local affiliate regulatory plans with global strategy and business priorities for labeling, risk management, and issue management.
  • Oversee US FDA submissions and agency engagement, including INDs, NDAs, and BLAs.
  • Ensure communications with FDA clearly present Lilly’s scientific position.
  • Develop productive FDA relationships in support of product registration goals.
  • Set strategic direction for a cross-functional Global Regulatory Team.
  • Encourage open communication, constructive feedback, and ongoing development.
  • Share key information to support global strategy execution and learning across functions.
  • Represent GRA at stakeholder and governance meetings, and mentor GRA colleagues.
  • Develop strategic relationships with external stakeholders.
  • Advise on promotional strategy and review press and investor relations materials in partnership with Regulatory Product Communications and Global Marketing.

Cerințe

  • Bachelor’s degree.
  • At least eight years of experience in regulatory affairs and/or drug development.
  • In-depth knowledge of global regulatory procedures, evolving reform initiatives, and integrated drug development.
  • Demonstrated experience with regulatory submissions and agency interactions in the US, EU, China, and Japan.
  • Direct experience in both clinical and CMC regulatory sciences.
  • Strong leadership, negotiation, and stakeholder communication skills, including with executive audiences.
  • Ability to assess and manage risk in a highly regulated setting.
  • Experience in the relevant therapeutic area.

Beneficii

  • Eligibility for a company bonus based partly on company and individual performance.
  • Company-sponsored 401(k) plan.
  • Pension.
  • Vacation benefits.
  • Medical, dental, vision, and prescription drug coverage.
  • Flexible benefits, including healthcare and/or dependent care flexible spending accounts.
  • Life insurance and death benefits.
  • Certain time-off and leave-of-absence benefits.
  • Well-being programs, including an employee assistance program, fitness benefits, and employee clubs and activities.
  • Relocation provided.
  • Expected travel of 10–15%.

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