Full-Time Specialist, Regulatory and PV Network

Specialist, Regulatory and PV Network is responsible for providing strategy based on regulatory requirements and completing regulatory and PV deliverables.

Responsibilities:

• Liaison between regulatory and other functional areas (external partners, clients, authorities, consultants) for planning, organizing, and preparing regulatory deliverables.
• Acts as Local Contact Person (LCP) for designated country.
• Assumes leadership and functional representation for projects of low complexity.
• Ensures effective coordination and management of deliverables to meet targets and comply with procedures.
• Provides intelligence on requirements, contributes to strategy development, and sets up activities (Project Management Plan, joint operating procedures, POAs, core documents).
• Supports identification of issues and corrective actions.
• Collects, reviews, tracks, and maintains LCPs' CVs, job descriptions, training records, contact details, and monthly reports.
• Ensures correct training assignment and compliance for LCPs.
• Identifies and escalates risk/potential risk to project team.
• Provides client expertise and guidance at national level.
• Maintains awareness of allocated tasks and hours, and escalates any OoS.
• Prepares client invoices and reviews/approves vendors' project invoices.
• Supports proposal development, inputs to budgets, and provides department representation to BD meetings.
• Fosters professional relationships with internal and external contacts.
• Stays abreast of changing regulatory requirements and maintains regulatory intelligence database.
• Participates in audits/inspections and provides department representation for assigned projects.
• Tracks LCPs' key performance indicators and prepares monthly summary reports.
• Provides feedback on vendors' performance.
• Communicates suggestions for changes to departmental/company processes/procedures.

Qualifications:

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.
• Previous experience within the pharmaceutical/CRO industry.
• PV training and/or working experience.
• Fluent in English, both written and verbal.
• Proficient in official language of based country.
• Good planning, organizational, and interpersonal skills.
• Strong attention to detail in a fast-paced environment.

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