Regulatory Affairs Manager

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

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 NCRs
• Safety labeling governance and compliance oversight of safety related labeling changes across global markets (i.e., accelerate 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 elevate when necessary

Education and/or Experience:

Bachelors 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.

Pay range:

35-45/hr

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