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Eli Lilly and Company
Eli Lilly and Company
औषधियाँजैव प्रौद्योगिकीस्वास्थ्य सेवा
Eli Lilly and Company एक बहुराष्ट्रीय फार्मास्यूटिकल और स्वास्थ्य सेवा कंपनी है, जो प्रिस्क्रिप्शन दवाओं की खोज, विकास, निर्माण और व्यावसायीकरण पर केंद्रित है। इसका कार्य मधुमेह, ऑन्कोलॉजी, इम्यूनोलॉजी, न्यूरोसाइंस और दर्द सहित विभिन्न उपचार क्षेत्रों में फैला है। कंपनी अनुसंधान और विकास को नैदानिक परीक्षणों, नियामक प्रक्रियाओं, जैविक और छोटे अणु वाली दवाओं के उत्पादन तथा वैश्विक वितरण के साथ जोड़ती है।
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कंपनी की नौकरियाँ

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.

USसंयुक्त राज्य
$1,75,500 – $2,57,400 / वर्ष
ऑन-साइटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

  • 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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