Senior Director, Regulatory Affairs Cmc

Alcon

Fort Worth, TX, US
Onsite
Global cmc regulatory strategy execution
Health authority communication and meetings
Biologics and pharmaceuticals compliance
This role is responsible for shaping and leading the execution of global CMC regulatory strategies for biologics, pharmaceuticals, and combination products across Alcon's portfolio

Job Summary

  • This role is responsible for shaping and leading the execution of global CMC regulatory strategies for biologics, pharmaceuticals, and combination products across Alcon's portfolio.
  • The successful candidate will represent the company in communications with health authorities to expedite approval of pending registrations and address questions.
  • Alcon offers a robust benefits package including health, life, retirement, flexible time off, and PTO for exempt associates.

Matching Summary

This role is responsible for shaping and leading the execution of global CMC regulatory strategies for biologics, pharmaceuticals, and combination products across Alcon's portfolio.

Skills & Requirements

Must-have

  • Global CMC regulatory strategy execution
  • Health authority communication and meetings
  • Biologics and pharmaceuticals compliance
  • CMC submission oversight and management
  • Risk assessment and mitigation planning

Nice-to-have

  • Strategic thinking and problem-solving abilities
  • Inclusive culture and team development
  • Business development integration experience
  • Continuous improvement commitment

Key Requirements

  • Bachelor's Degree required
  • 12 years of relevant experience
  • 8 years of demonstrated leadership
  • Fluent English communication skills
  • GxP regulations adherence

Work Rights

Not specified

Tailored Resume

Cover Letter