Hybrid Regulatory Affairs Manager – Safety Labeling Lead

Lancesoft; Deerfield (IL); Ibrido; USD 96.000 - 165.000; Tempo pieno

Descrizione del lavoro

Lancesoft in Deerfield, IL seeks a Senior Regulatory Affairs labeling specialist to oversee safety labeling variations for regulated pharmaceutical products, ensuring regulatory compliance and patient safety across global markets.

You will lead and coordinate with PV, Regulatory Affairs Labeling, and Global Labeling Operations, owning CCDS processes, monitoring variations, and driving governance and KPI reporting.

Competenze

• Bachelor's degree in a scientific discipline is required.
• Masters or PhD is an advantageous.
• Minimum of 5 years regulatory experience in RA or related field.
• Ability to manage complex projects in a matrix environment.
• Strong interpersonal, negotiation, and communication skills.

Mansioni

• Oversee safety labeling variations and ensure global regulatory compliance.
• Coordinate with PV, Regulatory Affairs Labeling, and Global Labeling Operations.
• Own safety labeling processes and CCDS-related governance.
• Monitor generic vs innovator labeling and PRAC triggers.
• Oversee safety labeling surveillance and compliance across markets.
• Lead KPI reporting and continuous improvement initiatives.
• Develop training materials for safety variation submissions.
• System owner for Fluxguard and CCDS/Safety Labeling tracking.
• Represent GRA on PV Safety Signal meetings.

Conoscenze

Scientific knowledge

Regulatory knowledge

Project management

Cross-functional collaboration

Negotiation skills

Communication and presentation

Multitasking and prioritization

Risk assessment and escalation

Formazione

Bachelor's degree in a scientific discipline

Masters or PhD preferred

Descrizione del lavoro

Lancesoft in Deerfield, IL seeks a Senior Regulatory Affairs labeling specialist to oversee safety labeling variations for regulated pharmaceutical products, ensuring regulatory compliance and patient safety across global markets.

You will lead and coordinate with PV, Regulatory Affairs Labeling, and Global Labeling Operations, owning CCDS processes, monitoring variations, and driving governance and KPI reporting.