Global Safety Labeling Strategist

Katalyst-Healthcares-; Deerfield (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst-Healthcares- seeks a senior Regulatory Affairs professional to provide strategic oversight of safety labeling variations for regulated pharmaceutical drug products. You will ensure global regulatory compliance, patient safety and consistent product information communication.

The role requires leadership across PV, Regulatory Affairs Labeling and Global Labeling Operations, ownership of CCDS processes, and ongoing improvement of safety variation submissions.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree advantageous.
• Minimum 5 years regulatory experience in RA or related field, including people or project management.
• Strong regulatory knowledge and ability to manage complex, cross-functional programs.

Responsibilities

• Oversee safety labeling variations and regulatory compliance across global markets.
• Lead safety labeling governance and oversee CCDS and safety variation processes.
• Interface with PV, Regulatory Affairs Labeling and Global Labeling Operations; drive KPI reporting and continuous improvement.
• Support inspections related to safety labeling and participate in safety signal meetings.

Skills

Regulatory knowledge

Project management

Multitasking

Communication

Leadership

Education

Bachelor's degree in science

Masters/PhD advantage

Tools

Fluxguard

Job description

Katalyst-Healthcares- seeks a senior Regulatory Affairs professional to provide strategic oversight of safety labeling variations for regulated pharmaceutical drug products. You will ensure global regulatory compliance, patient safety and consistent product information communication.

The role requires leadership across PV, Regulatory Affairs Labeling and Global Labeling Operations, ownership of CCDS processes, and ongoing improvement of safety variation submissions.