Senior Principal Scientist – Regulatory GRA‑CMCD

About the role

Eli Lilly’s Lifecycle Innovation group in GRA‑CMCD is seeking a Senior Principal Scientist to lead post‑approval CMC regulatory strategy for its global commercial portfolio. You will work closely with manufacturing, quality, and supply‑chain teams to ensure regulatory excellence throughout the product lifecycle.

Key responsibilities

• Develop and execute global post‑approval CMC regulatory strategies.
• Collaborate with manufacturing sites, quality assurance, and supply chain to support change management.
• Drive process simplification and improve submission efficiency.
• Apply innovative digital approaches to regulatory change management.
• Provide tactical and operational guidance to internal CMC stakeholders.

Required profile

• Extensive experience in pharmaceutical regulatory affairs, specifically CMC.
• Proven ability to build productive relationships with cross‑functional manufacturing teams.
• Strong understanding of global post‑approval change management processes.
• Excellent communication and strategic thinking skills.

Required skills

• Regulatory strategy development
• CMC (Chemistry, Manufacturing, and Controls) expertise
• Post‑approval change management

What we offer

• Hybrid working model with flexible onsite options.
• Comprehensive health, pension and life assurance benefits.
• Subsidised canteen, onsite gym, travel subsidies and parking.
• In‑house people development services and educational assistance.
• Inclusive diversity, equity and inclusion initiatives.