Global Regulatory Lead at Eli Lilly
Overview
Lead the development and execution of global regulatory strategies overseeing the entire lifecycle of products. Drive robust regulatory approaches while aligning local plans with global objectives. This role shapes the external regulatory environment and mentors a cross-functional team. It is a purpose-driven opportunity to impact patient outcomes worldwide.
What You'll Do11
- 1Design and lead innovative global regulatory strategies from candidate selection to end of lifecycle
- 2Integrate competitive intelligence and health authority guidance to create forward-looking strategies
- 3Spearhead regulatory representation on the Global Brand Development team addressing labeling risk management and issues management
- 4Oversee all US FDA submissions including INDs NDAs and BLAs ensuring high-quality communications
- 5Build productive relationships with FDA to support product registration goals
- 6Provide strategic direction to a cross-functional Global Regulatory Team including regional scientists and GRA specialists
- 7Foster transparent communication within the team and share insights for seamless execution
- 8Represent GRA at stakeholder meetings and mentor personnel
- 9Shape external regulatory environment through partnerships with Regulatory Product Communications and Global Marketing
- 10Collaborate with Therapeutic Area experts to understand global procedures and reforms
- 11Manage travel expectations of 10–15% while supporting diverse stakeholder engagement
Requirements8
- 1Advanced scientific degree PharmD PhD with 8+ years regulatory affairs experience or Bachelor’s/Masters with 10+ years experience
- 2Deep knowledge of global regulatory procedures and integrated drug development processes
- 3Proven experience with submissions across US EU China Japan including IND NDA BLA
- 4Direct experience in clinical and CMC regulatory sciences
- 5Strong leadership negotiation and stakeholder communication skills including executive audiences
- 6Ability to assess and manage risk in highly regulated environments
- 7Therapeutic area expertise required
- 8Accommodation request available via designated form for application consideration
Salary Insight
$170 - $249k per year
Location
Required Skills
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