Global Regulatory Affairs CMC Lead – Biologics & Non-Bio

Global Regulatory Affairs CMC Lead – Biologics & Non-Bio

Full-Time 49500 - 60500 $ / year (est.) On-site
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At a Glance

  • Tasks: Lead regulatory strategy for biologics and non-bio products, ensuring compliance and timely submissions.
  • Company: CSL, a global leader in biopharmaceuticals with a commitment to innovation.
  • Benefits: Competitive salary, health benefits, and opportunities for professional growth.
  • Other info: Collaborative environment with diverse teams and global reach.
  • Why this job: Make a real impact in global health by driving regulatory solutions.
  • Qualifications: Experience in regulatory affairs and strong leadership skills.

The predicted salary is between 49500 - 60500 $ per year.

CSL is seeking a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy across biological and non-biol. product portfolios.

You will lead submissions, coordinate cross-functional teams, and ensure compliance with global standards.

You will collaborate with R&D, Manufacturing, Quality, and Regulatory Affairs to deliver timely regulatory solutions and manage interactions with agencies worldwide.

Global Regulatory Affairs CMC Lead – Biologics & Non-Bio employer: CSL

CSL is an exceptional employer that fosters a collaborative and innovative work culture, making it a leader in the biotechnology sector. With a strong commitment to employee growth, CSL offers extensive professional development opportunities and the chance to work on impactful projects across the Asia Pacific region. Located in Australia, employees benefit from a supportive environment that values diversity and inclusion, ensuring a rewarding career path in a company dedicated to saving lives.

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Contact Details:

CSL Recruitment Team

We think you need these skills to ace Global Regulatory Affairs CMC Lead – Biologics & Non-Bio

Regulatory Affairs
CMC Regulatory Strategy
Submission Management
Cross-Functional Team Coordination
Compliance with Global Standards
Collaboration with R&D
Manufacturing Knowledge