Regulatory Affairs Manager, Pharmacovigilance

This is a fully remote position, open to applicants in Romania.

📋 Description

• Act as the regulatory authority for the Central Cluster nations, delivering strategic guidance to enhance business goals and patient accessibility.

• Serve as the main point of contact for Regulatory Affairs with Romania's National Agency for Medicines and Medical Devices, overseeing and coordinating local regulatory activities.

• Collaborate with Regulatory Authorities in the cluster countries to ensure efficient communication, alignment, and execution of regulatory tasks.

• Develop regulatory strategies for managing product lifecycles, expanding markets, and fostering regional growth.

• Work in partnership with teams from Medical Affairs, Market Access, Commercial, Supply Chain, Quality, and Global Regulatory Affairs.

• Analyze changing regulatory requirements, pinpoint opportunities, and reduce risks.

• Supervise cluster regulatory operations and the activities of external regulatory service providers.

• Contribute to regional and global initiatives while aiding in the realization of the company's regulatory vision and strategy.

• Serve as the local expert in pharmacovigilance, overseeing safety monitoring, risk management, and compliance with PV standards.

• Ensure adherence to EU GVP requirements, local regulations, safety agreements, and company protocols.

• Act as the primary contact for Health Authorities, partners, and key stakeholders in pharmacovigilance matters.

• Oversee the management of Individual Case Safety Reports (ICSR), reconciliations, local literature reviews, and safety intelligence efforts.

• Manage Risk Management Plans and implement additional risk minimization strategies.

• Maintain readiness for inspections and audits, including CAPA management and monitoring of PV compliance.

• Oversee pharmacovigilance service providers and outsourced activities.

• Participate in regional and global cross-functional pharmacovigilance projects.

• Cultivate relationships across a diverse, multicultural organization while balancing compliance requirements with business objectives.

⛳️ Requirements

• A minimum of 6 years of experience in Regulatory Affairs within the pharmaceutical sector.

• Practical experience managing regulatory activities across various countries or regional markets.

• At least 2 years of experience in Pharmacovigilance.

• Experience in supporting innovative pharmaceutical products, including product launches and lifecycle management.

• Comprehensive understanding of EU regulatory requirements, EU GVP guidelines, and pharmaceutical compliance standards.

• Proven experience in interactions with health authorities, vendors, and cross-functional stakeholders.

• Experience in vendor oversight is required.

• Experience in pharmacovigilance auditing and readiness for inspections is highly advantageous.

• A degree in Pharmacy, Life Sciences, Biology, Chemistry, or a related scientific field.

• Proficient in English.

• Strong skills in stakeholder management, communication, and relationship-building.

• Capability to excel in a dynamic international setting and effectively manage multiple priorities across a varied regional landscape.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness programs.

• Flexible working arrangements to support work-life balance.