Specialist, Regulatory and Pharmacovigilance Network - Remote

Overview

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.

In Short

• Lead and manage low complexity projects ensuring timely deliverables.
• Develop regulatory strategy and project management plans.
• Maintain LCPs' documentation and training compliance.
• Identify and escalate project risks promptly.
• Provide expertise and guidance at a national level.
• Prepare and review client invoices and vendor project invoices.
• Support proposal development and budget input.
• Foster relationships with internal and external stakeholders.
• Stay updated on regulatory changes and maintain intelligence database.
• Participate in audits and prepare summary reports.

Requirements

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

Benefits

• Training and career development opportunities.
• Emphasis on personal and professional growth.
• Friendly and supportive working environment.
• Opportunity to work with a global team.