Regulatory Affairs Manager

Lancesoft; Deerfield (IL); Hybrid; USD 96,000 - 165,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Scientific knowledge

Regulatory knowledge

Project management

Cross-functional collaboration

Negotiation skills

Communication and presentation

Multitasking and prioritization

Risk assessment and escalation

Education

Bachelor's degree in a scientific discipline

Masters or PhD preferred

Job description

Responsible for strategic oversight of safety related labeling variations impacting regulated pharmaceutical drug products while ensuring regulatory compliance, patient safety, and consistent communication of product information across global markets. 3 days onsite required/2 days remote

Essential Duties and Responsibilities

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

Key Interface between Pharmacovigilance (PV), Regulatory Affairs Labeling Team and Global Labeling Operations Ownership and Establishment of Safety Labeling Processes for GRA including but not limited to:

• CCDS and associated Safety Variations
• Generic Labeling and Monitoring of Innovator Labels
• PRAC and MOH triggers
• Oversee generic labeling surveillance and innovator-label monitoring
• Oversee PRAC recommendations
• Lead continuous improvement and KPI reporting including but not limited to CCDS metrics including coordination of Client s Safety labeling governance and compliance oversight of safety related labeling changes across global markets (i.E., escalates risks associated with overdue safety variations)
• Develop Training Materials for improved safety variation submission process and related system changes
• System Owner for Fluxguard and CCDS/Safety Labeling Tracking Support PV and RA inspections as it relates to safety labeling
• Represent GRA function on PV Safety Signal Meeting

Qualifications

Scientific knowledge Ability to multitask and prioritize Ability to work effectively in multinational/multicultural environment Sound basis of Regulatory knowledge Management skills Ability to manage complex projects and timelines in a matrix team environment Strong interpersonal, communication and presentation skills Demonstrated interpersonal skills including strong negotiation skills Technical and management skills Ability to lead and coach others Ability to independently identify compliance risks and escalates when necessary

Education and/or Experience

Bachelor s degree or country equivalent in a scientific discipline Masters and/or PhD will be an advantage. Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.

Max Bill Rate: ***/hour