We are looking for a position of:
Head of Medical Affairs Department
Location: Lublin/Poland

We are partnering with a biotechnology/pharmaceutical company focused on creating biological drugs that are based on microorganisms and blood derivatives. Their products are distributed globally, reaching 50 countries. They aim to become a leading force in the Life Science industry, setting new benchmarks and trends. To achieve this, we are seeking an experienced individual to lead the registration department and help improve current processes. The ideal candidate should have a proven track record in developing successful strategies for entering new markets with pharmaceutical products.

Key tasks:

• Development and implementation of a new/optimal strategy and process for registration of a pharmaceutical products (based on microorganisms and blood derivatives) in the Polish, EU, CIS and other markets (including the US).
• Monitoring and developing the entire product registration process, including pharmacovigilance monitoring.
• Generating and implementing improvements to the registration process.
• Overseeing the assessment of all registration dossiers, including reviewing and approving protocols, reports and registration documents.
• Cooperation with appropriate external registration units, e.g. Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
• Conducting audits of registration processes and mitigating risks.
• Development of printed materials: cooperation with the scientific department, marketing department, graphic designer.
• Supervision of the budget and department resources.

Requirements:

• MSc/PhD in medicine, pharmacy, biotechnology, biology or related fields.
• At least 8 years of experience in registering medicinal products and a minimum of 4 years of management experience.
• Highly preferred expertise in regulatory department management.
• Experience in operational processes, including establishing a strategy and improving a process for registering new medicinal products (biological drugs) for new markets.
• Knowledge of pharmaceutical legislation, particularly current EMA and ICH guidelines regarding detailed registration documentation, is also required.
• General knowledge of rules and regulations in preclinical and clinical research is a plus.
• Ability to report post-registration changes.
• Knowledge of document management systems (software) and experience in implementations of such systems will be a plus.
• Nice-to-have qualifications include knowledge of the development of medicinal products in the initial phase.
• High level of energy, ideas for improvement and change implementation.
• Strong communication and leadership skills.
• Excellent English language proficiency required.

We offer:
• High level of independence and responsibility for decision-making.
• Significant impact on the organization.
• Work in stablished, recognizable, and growing organization with an international presence.
• Full-time employment contract with occasional travel.
• Preferred location at company headquarters in Lublin.
• Hybrid work possible after.

We would be happy to discuss the career opportunities and guide you through the recruitment process.