Regulatory Affairs Manager, Pharmacovigilance

Job not on LinkedIn

🔥 1 minute ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Medison Pharma

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

Medison Pharma is a global pharmaceutical company focused on providing access to highly innovative therapies to patients in international markets. The company has pioneered an international commercialization platform aimed at facilitating the accessibility of novel treatments, thereby saving and improving lives. Medison Pharma has established a strong history of multi-territorial partnerships with leading pharmaceutical and biotech companies to help expand their global reach.

📋 Description

• Serve as the regulatory expert for the Central Cluster countries, providing strategic guidance to support business objectives and patient access • Act as the primary Regulatory Affairs point of contact with Romania's National Agency for Medicines and Medical Devices, coordinating and managing local regulatory affairs activities • Liaise with Regulatory Authorities in cluster countries, ensuring effective communication, alignment, and execution of regulatory activities • Shape regulatory strategies for product lifecycle management, market expansion, and regional growth • Partner with Medical Affairs, Market Access, Commercial, Supply Chain, Quality, and Global Regulatory Affairs teams • Interpret evolving regulatory requirements, identify opportunities, and mitigate risks • Oversee cluster regulatory operations and external regulatory service providers • Support regional and global initiatives and contribute to the company's regulatory vision and strategy • Serve as the local pharmacovigilance expert, overseeing safety surveillance, risk management, and PV compliance • Ensure compliance with EU GVP requirements, local regulations, safety agreements, and company standards • Act as the primary PV contact for Health Authorities, partners, and key stakeholders • Oversee ICSR management, reconciliations, local literature monitoring, and safety intelligence activities • Manage Risk Management Plans and additional risk minimization measures • Maintain inspection and audit readiness, including CAPA management and PV compliance monitoring • Manage PV service providers and outsourced pharmacovigilance activities • Contribute to regional and global cross-functional PV projects • Build relationships across a multicultural, geographically dispersed organization while balancing compliance and business needs

🎯 Requirements

• Minimum 6 years of experience in Regulatory Affairs within the pharmaceutical industry • Hands-on experience managing regulatory activities across multiple countries or regional markets • At least 2 years of Pharmacovigilance experience • Experience supporting innovative pharmaceutical products, including product launches and lifecycle management • Strong knowledge of EU regulatory requirements, EU GVP guidelines, and pharmaceutical compliance standards • Experience interacting with health authorities, vendors, and cross-functional stakeholders • Experience in vendor oversight • Pharmacovigilance auditing and inspection readiness experience is highly desirable • Degree in Pharmacy, Life Sciences, Biology, Chemistry, or related scientific discipline • Fluent English • Strong stakeholder management, communication, and relationship-building skills • Ability to thrive in a dynamic international environment and effectively manage multiple priorities across a diverse regional scope

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume