Gra Cmc Specialist

CSL Behring

Not specified
Plan regulatory affairs activities
Acquire permits and approvals
Monitor regulatory developments
CSL Behring is seeking a Gra Cmc Specialist to oversee and manage regulatory affairs activities within the pharmaceutical industry, with a focus on obtaining necessary permits and maintaining relationships with regulatory bodies. The ideal candidate will have at least three years of regulatory experience, preferably in biologics, and will contribute to the organization’s mission of providing innovative therapies that improve patient lives

Job Summary

  • The role involves planning and directing regulatory affairs to ensure the organization holds all necessary permits and licenses for business operations.
  • Candidates will be responsible for acquiring permits, monitoring regulatory changes, and representing the company before legislative or industry standards agencies.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other areas.

Matching Summary

Match Score: 85

CSL Behring is seeking a Gra Cmc Specialist to oversee and manage regulatory affairs activities within the pharmaceutical industry, with a focus on obtaining necessary permits and maintaining relationships with regulatory bodies. The ideal candidate will have at least three years of regulatory experience, preferably in biologics, and will contribute to the organization’s mission of providing innovative therapies that improve patient lives.

Skills & Requirements

Must-have

  • Plan regulatory affairs activities
  • Acquire permits and approvals
  • Monitor regulatory developments
  • Prepare registration application documentation
  • Maintain regulatory systems data

Nice-to-have

  • Establish positive government relationships
  • Represent organization before agencies
  • Support consistent work processes
  • Advise management on regulation impact

Key Requirements

  • Bachelor degree in Life Science or Business
  • 3+ years regulatory experience in pharmaceutical industry
  • Biologics Regulatory experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter