EU Regulatory Strategy Director — Senior Leader

BioSpace; Indianapolis (IN); On-site; USD 161,000 - 260,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical, dental, vision coverage

Flexible benefits

Paid time off and holidays

Employee resource groups

Job summary

Lilly, Centessa Pharmaceuticals, is seeking a Senior Director, European Regulatory Strategy in the UK to lead regulatory planning and submissions across the EU, UK and Switzerland, interfacing with EMA, MHRA and Swissmedic. You will guide pediatric development and coordinate with global partners to ensure timely registrations and lifecycle management.

You will drive regulatory excellence in a fast-paced, matrixed environment and mentor teams to deliver data-driven regulatory narratives.

Qualifications

• Bachelor's degree in a scientific discipline with 12+ years regulatory affairs experience in pharma/biotech.
• Advanced degree (PhD, PharmD, MS, or JD) strongly preferred.
• Significant experience leading European regulatory strategies and health authority interactions.
• Experience with EU pediatric regulatory strategy and submissions.
• Experience with MAAs, CTAs, pediatric submissions, and briefing documents.

Responsibilities

• Serve as the European Regulatory Lead for lead programs from development through lifecycle management.
• Develop and execute regulatory strategies across EU, UK, Switzerland, and other regions.
• Lead planning, preparation, and submission of MAAs, CTAs, pediatric submissions and briefing documents.
• Represent the company in regulatory interactions with EMA, EU NCAs, MHRA, and Swissmedic.
• Provide regulatory guidance to cross-functional program teams.
• Oversee external EU regulatory consultants and vendors.
• Collaborate with global regulatory colleagues to align strategies across regions.

Skills

Regulatory leadership

Regulatory strategy

Regulatory submissions

Health authority interactions

EU regulatory requirements

Pediatric development

Matrixed environment

Stakeholder communication

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Lilly, Centessa Pharmaceuticals, is seeking a Senior Director, European Regulatory Strategy in the UK to lead regulatory planning and submissions across the EU, UK and Switzerland, interfacing with EMA, MHRA and Swissmedic. You will guide pediatric development and coordinate with global partners to ensure timely registrations and lifecycle management.

You will drive regulatory excellence in a fast-paced, matrixed environment and mentor teams to deliver data-driven regulatory narratives.