Regulatory Affairs Manager

Spectraforce Technologies, Inc.; Deerfield (IL); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Manager in Deerfield, IL to oversee safety label variations and ensure global regulatory compliance.

The role interfaces with PV and labeling teams to drive CCDS processes, monitor generic and innovator labeling, and lead improvements in safety labeling governance. The candidate will develop training for variation submissions, own Fluxguard and CCDS tracking, and support inspections related to safety labeling across markets.

Qualifications

• Bachelor's degree or country equivalent in a scientific discipline; Masters/PhD preferred.
• Minimum 5 years regulatory experience in RA or related field, including managing people or projects.
• Strong regulatory knowledge and ability to identify compliance risks.
• Ability to lead and coach others in a matrix team environment.

Responsibilities

• Key interface between PV, Regulatory Affairs Labeling Team and Global Labeling Operations.
• Ownership and establishment of safety labeling processes for GRA including CCDS and safety variations.
• Oversee generic labeling surveillance and innovator-label monitoring.
• Oversee PRAC recommendations.
• Lead KPI reporting including CCDS metrics and NCR coordination.
• Safety labeling governance and compliance oversight across global markets.
• Develop training materials for safety variation submissions and system changes.
• System owner for Fluxguard and CCDS/Safety Labeling Tracking.
• Support PV and RA inspections related to safety labeling.
• Represent GRA function on PV Safety Signal Meeting.

Skills

Scientific knowledge

Multitasking ability

Multicultural environment

Regulatory knowledge

Management skills

Project leadership

Communication skills

Negotiation skills

Technical skills

Leadership coaching

Compliance risk identification

Education

Bachelor's degree in a scientific field

Masters or PhD (advantage)

Tools

Fluxguard

CCDS tracking

Job description

Job Title: Regulatory Affairs Manager

Location: Deerfield, IL, 60015 (3 days onsite required/2 days remote)

Duration: 12 months

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.

Essential Duties and Responsibilities:

• 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 NCR's
• Safety labeling governance and compliance oversight of safety related labeling changes across global markets (i.e., elevate 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:

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.