Global Regulatory Labelling Specialist

Job Description

Job Title: Global Regulatory Labelling Specialist

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

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Duration: 12 months

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Description:

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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.

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Essential Duties and Responsibilities:

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

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• Key Interface between Pharmacovigilance (PV), Regulatory Affairs Labeling Team and Global Labeling Operations

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• Ownership and Establishment of Safety Labeling Processes for GRA including but not limited to:

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- CCDS and associated Safety Variations

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- Generic Labeling and Monitoring of Innovator Labels

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- PRAC and MOH triggers

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• Oversee generic labeling surveillance and innovator-label monitoring

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• Oversee PRAC recommendations

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• Lead continuous improvement and KPI reporting including but not limited to CCDS metrics including coordination of NCR’s

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• Safety labeling governance and compliance oversight of safety related labeling changes across global markets (i.e., escalate risks associated with overdue safety variations)

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• Develop Training Materials for improved safety variation submission process and related system changes

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• System Owner for Fluxguard and CCDS/Safety Labeling Tracking

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• Support PV and RA inspections as it relates to safety labeling

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• Represent GRA function on PV Safety Signal Meeting

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Qualifications:

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• Scientific knowledge

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• Ability to multitask and prioritize

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• Ability to work effectively in multinational/multicultural environment

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• Sound basis of Regulatory knowledge

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• Management skills

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• Ability to manage complex projects and timelines in a matrix team environment

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• Strong interpersonal, communication and presentation skills

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• Demonstrated interpersonal skills including strong negotiation skills

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• Technical and management skills

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• Ability to lead and coach others

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• Ability to independently identify compliance risks and escalate when necessary

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Education and/or Experience:

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Bachelor’s degree or country equivalent in a scientific discipline

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Masters and/or PhD will be an advantage.

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Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.

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Applicant Notices & Disclaimers

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• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
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