Senior Regulatory Affairs Expert for Global Labeling

1 week ago

Washington, Washington, D.C., United States Lifelancer Full time
Expert in Global Regulatory Affairs

We are seeking a highly skilled Senior Regulatory Affairs expert to join our team as a Global Labeling Specialist.

About the Role:

  • The ideal candidate will have 10+ years of experience in the pharmaceutical industry, with at least 4 years of direct regulatory affairs experience, including CCDS and US/EU labeling.
  • They will be responsible for ensuring compliance with global labeling regulations and guidances, reviewing US and EU package inserts, and managing labeling deviations.
  • As a key member of our team, they will establish process best practices, mentor junior staff, and develop Standard Operating Procedures (SOPs).

About Us:

Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We offer competitive compensation packages that align with market standards.

Key Responsibilities:

  1. Develop and implement regulatory documents, including draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, EU PL, CCDS, and CCPL.
  2. Collaborate with cross-functional teams on RA labeling issues and ensure alignment with company business objectives.
  3. Conduct label review committee meetings and lead review processes to ensure compliance with internal and external labeling guidelines.
  4. Establish relationships with cross-functional and cross-regional representatives on labeling review teams and partner companies.

What You'll Get:

  • A competitive salary range: $120,000 - $160,000 per year, depending on experience.
  • A comprehensive benefits package, including medical, dental, and vision coverage.
  • Opportunities for career growth and professional development.

Requirements:

  • Bachelor's degree in a scientific discipline; advanced degree preferred.
  • Experience working with country labeling outside the US/EU a plus.
  • Demonstrated expertise in global labeling regulations and guidances.

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