USA - Regulatory Affairs Manager # 26-26711

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Duration: 12 Months Contract (Extension Possible)

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: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 OperationsOwnership and Establishment of Safety Labeling Processes for GRA including but not limited to:CCDS and associated Safety VariationsGeneric Labeling and Monitoring of Innovator LabelsPRAC and MOH triggersOversee generic labeling surveillance and innovator-label monitoringOversee PRAC recommendationsLead continuous improvement and KPI reporting including but not limited to CCDS metrics including coordination of Client’sSafety labeling governance and compliance oversight of safety related labeling changes across global markets (i.e., escalate risks associated with overdue safety variations)Develop Training Materials for improved safety variation submission process and related system changesSystem Owner for Fluxguard and CCDS/Safety Labeling TrackingSupport PV and RA inspections as it relates to safety labelingRepresent GRA function on PV Safety Signal Meeting Qualifications:Scientific knowledgeAbility to multitask and prioritizeAbility to work effectively in multinational/multicultural environmentSound basis of Regulatory knowledgeManagement skillsAbility to manage complex projects and timelines in a matrix team environmentStrong interpersonal, communication and presentation skillsDemonstrated interpersonal skills including strong negotiation skillsTechnical and management skillsAbility to lead and coach othersAbility to independently identify compliance risks and escalate when necessary

Education and/or Experience:Bachelor’s degree or country equivalent in a scientific disciplineMasters and/or PhD will be an advantage. Minimum of 5-year regulatory experience in RA or related field, including managing people or projects. About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. xzbcwsv

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