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Regulatory Affairs & Pharmacovigilance Manager

medison/67.00a61 open roles

Where
Romania
Work mode
Hybrid
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Your applicationOpen nowRegulatory Affairs & Pharmacovigilance Managermedison/67.00a · Romania

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The clock on this job

Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market. medison/67.00a postings stay open a median of 2 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: first seen 1 hour ago

medison/67.00a median: 2 days open

The posting

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.

Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 35 countries across 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!

The Manager, Regulatory Affairs & Pharmacovigilance for the Central Cluster (Romania, Moldova, Hungary, Czech Republic, Slovakia) will oversee regulatory and pharmacovigilance operations to ensure compliance with local and international regulatory requirements, support continuous improvement initiatives, and manage RA/PV activities while reporting directly to the Head of Regulatory Affairs & Pharmacovigilance, EPM, actively contributing to regional and EPM-wide regulatory and safety strategies.

Responsibilities

Regulatory Affairs

  • Serve as the regulatory expert for the cluster countries, providing strategic guidance to support business objectives and patient access.
  • Acts as the primary Regulatory Affairs point of contact between the company and national Agency for Medicines and Medical Devices of Romania, coordinating and managing all relevant local regulatory affairs activities
  • Acts as the key liaison with Regulatory Authorities in cluster countries, ensuring effective communication, alignment, and execution of regulatory affairs activities
  • Shape regulatory strategies that enable successful product lifecycle management, market expansion, and sustainable regional growth.
  • Partner closely with cross-functional teams including Medical Affairs, Market Access, Commercial, Supply Chain, Quality, and Global Regulatory Affairs to support critical business decisions.
  • Anticipate and interpret evolving regulatory requirements, proactively identifying opportunities and mitigating potential risks.
  • Oversee cluster regulatory operations and external regulatory service providers / third parties to ensure excellence in execution and compliance.
  • Support regional and global initiatives while contributing to the development and implementation of the company's regulatory vision and strategy.

Pharmacovigilance

  • Serve as the local pharmacovigilance expert for the cluster countries, ensuring safety surveillance, risk management, and PV compliance activities across the product portfolio.
  • 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 as applicable.
  • Oversee cluster pharmacovigilance activities including ICSR management, reconciliations, local literature monitoring and safety intelligence activities.
  • Manage the implementation and oversight of Risk Management Plans (RMPs) and additional risk minimization measures.
  • Maintain continuous inspection and audit readiness, including CAPA management and PV compliance monitoring.
  • Manage and oversee PV service providers ensuring compliant and effective execution of outsourced pharmacovigilance activities.
  • .Contribute to regional and global cross-functional PV projects supporting Medison's growth and strategic objectives.
  • Build strong relationships across a multicultural and geographically dispersed organization while balancing compliance requirements with 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.
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