Global CMC Regulatory Science Lead

Global CMC Regulatory Science Lead

Full-Time 80000 - 100000 Β£ / year (est.) No working from home possible
Moderna

At a Glance

  • Tasks: Lead global CMC regulatory strategy and oversee agency correspondence.
  • Company: Join Moderna, a pioneering biotech company at the forefront of innovation.
  • Benefits: Competitive salary, health benefits, and opportunities for professional growth.
  • Other info: Dynamic role with opportunities to interact with health authorities globally.
  • Why this job: Make a real impact in the biotech field and drive regulatory success.
  • Qualifications: 10+ years in pharma/biotech with biologics-focused Regulatory CMC experience.

The predicted salary is between 80000 - 100000 Β£ per year.

Moderna is seeking an Associate Director, CMC Regulatory Science-International to lead global CMC regulatory strategy and oversee agency correspondence and regulatory applications from our Harwell site. You will drive submission readiness, provide expert guidance to development teams, and interact with health authorities to facilitate approvals.

The role requires 10+ years in pharma/biotech with biologics-focused Regulatory CMC experience, and a strong understanding of EU/ROW regulations and CTD.

Global CMC Regulatory Science Lead employer: Moderna

Moderna in Oxford is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the field of laboratory automation. Employees benefit from comprehensive growth opportunities, mentorship programs, and the chance to contribute to groundbreaking mRNA science, all while working in a state-of-the-art facility that prioritises efficiency and excellence in clinical development.

Moderna

Contact Details:

Moderna Recruitment Team

We think you need these skills to ace Global CMC Regulatory Science Lead

Global CMC Regulatory Strategy
Agency Correspondence
Regulatory Applications
Submission Readiness
Expert Guidance
Health Authority Interaction
Pharma/Biotech Experience