HCC Coordinator – Pharmaceutical Regulatory Affairs

Role Purpose 

To coordinate and provide analytical support on regulatory matters for the Healthcare Committee, with a focus on medicinal product regulation, including marketing authorisation and lifecycle management, pharmacovigilance, medicinal product importation, and quality control. The role combines regulatory expertise, legislative analysis, coordination of member companies’ positions, and preparation of materials to support advocacy efforts. 

Key Qualifications and Requirements 

• A university degree in pharmacy, medicine, natural sciences, law, or another relevant field. A degree in pharmacy will be a significant advantage. 

• At least 3–5 years of relevant experience in pharmaceutical regulatory affairs, regulatory policy, legal and regulatory support, engagement with public authorities, or a related field. 

• Practical experience and in-depth knowledge of at least one of the following areas of pharmaceutical regulation: medicinal product registration and lifecycle management; pharmacovigilance; medicinal product importation, quality control, and related regulatory requirements. 

• A general understanding of the regulatory framework in the other areas listed above, along with the ability to quickly develop expertise in related regulatory matters. 

• Experience analysing legislation, draft laws, and secondary legislation, as well as assessing their potential impact on pharmaceutical companies’ operations. 

• The ability to work with large volumes of regulatory and legal information, identify key issues, and translate technical matters into clear and well-structured positions. 

• Strong written and verbal communication skills, with the ability to engage professionally with member companies, representatives of public authorities, and other stakeholders. 

• Fluency in Ukrainian and English. 

• Strong analytical and organisational skills, attention to detail, and the ability to manage several regulatory workstreams simultaneously while meeting tight deadlines. 

Would Be an Advantage 

• Experience working for a pharmaceutical company, business association, consultancy, law firm, or public authority involved in pharmaceutical regulation. 

• Experience preparing regulatory comments, proposals, position papers, official correspondence, and/or proposed amendments to draft legislation and regulations. 

• Experience in advocacy and/or government relations, including coordinating discussions among different stakeholders and consolidating the positions of multiple companies into a common position. 

• Knowledge of EU pharmaceutical legislation and the processes involved in aligning Ukrainian legislation with the EU acquis.