Hybrid Regulatory Affairs Manager, Safety Labeling & Compliance

Planet Pharma; Deerfield (IL); Hybrid; USD 48,000 - 62,000; Full time

Job summary

Planet Pharma in Deerfield, IL seeks a senior Regulatory Affairs / GRA professional to oversee safety labeling variations and ensure global compliance and clear communications of product information. The role interacts with PV, Regulatory Affairs Labeling Team, and Global Labeling Operations, driving process ownership and change control.

You will lead labeling processes, monitor variations, manage PRAC/MOH triggers, and contribute to KPI reporting.

Qualifications

• Bachelor's degree or country equivalent in a scientific discipline.
• Master's degree or PhD preferred.
• Minimum of 5 years regulatory experience in RA or related field, with people or project leadership.

Responsibilities

• Key interface between PV, Regulatory Affairs Labeling Team and Global Labeling Operations.
• Ownership and establishment of safety labeling processes for GRA incl. CCDS variations.
• Oversee CCDS and associated safety variations; monitor labels.
• PRAC and MOH triggers; oversee PRAC recommendations.
• Lead continuous improvement and KPI reporting incl. CCDS metrics and NCR coordination.
• Safety labeling governance and compliance across global markets; accelerate overdue variations.
• Develop training materials for submission process and system changes.
• System owner for Fluxguard and CCDS/safety labeling tracking.
• Support PV and RA inspections related to safety labeling.
• Represent GRA on PV Safety Signal meetings.

Skills

Scientific knowledge

Multitask & prioritize

Multinational environment

Regulatory knowledge

Management skills

Project management

Interpersonal skills

Negotiation skills

Technical leadership

Coaching others

Compliance risk identification

Education

Bachelor's degree in a scientific discipline

Master's degree or PhD advantageous

Tools

Fluxguard

Job description

Planet Pharma in Deerfield, IL seeks a senior Regulatory Affairs / GRA professional to oversee safety labeling variations and ensure global compliance and clear communications of product information. The role interacts with PV, Regulatory Affairs Labeling Team, and Global Labeling Operations, driving process ownership and change control.

You will lead labeling processes, monitor variations, manage PRAC/MOH triggers, and contribute to KPI reporting.