Regulatory Affairs Specialist - София

Our client is the Bulgarian representative office of a Leading Global Pharmaceutical Company. The company is specialized in manufacturing and marketing of I.V. generic drugs, infusion therapies, clinical nutrition products as well as medical devices. Due to expansion of its business activities, our Client is opening the following new position:

Regulatory Affairs Specialist

Main Responsibilities:
• Performance of operational aspects in the process of preparation of regulatory submissions for medicinal products and food range products
• Performance of operational aspects as part of product life cycle management
• Operating with product related information in accordance with legal and regulatory requirements (labelling management)
• Maintaining a deep understanding of new and existing regulations impacting organization’s products and processes
• Interfaces with Health Authorities regarding submission activities
• Reviewing legal, technical, marketing documentation for compliance assessment
• Preparation of reports/documents based on specific demands and compliance status reporting
• Dealing with specific regulatory applications and databases maintenance
• Cooperative working relationship with other team members for assigned projects


Requirements:
• University degree (Life Sciences, Medical, Pharmacy or relevant)
• 1-2 years experience in regulatory affairs field
• Good knowledge of the Bulgarian and European applicable legislation
• Good organizational and planning skills, prioritization skills and multiple project tasking
• Analytical thinking and strong attention to details
• Responsible, reliable, loyal
• Ability to work effectively in a team, including in a multinational one
• Аdvanced knowledge in English is mandatory
• РC skills are mandatory (Word, Excel, PowerPoint, Internet)

The company offers:
• Opportunity to become part of global healthcare company operating with a high level of personal commitment, passion, and integrity in a collaborative work environment
• Opportunities for further professional development and experiencing
• Good remuneration package


If you are interested in this opportunity and cover the above profile’s requirements, please apply by sending your CV and Motivation Letter. We appreciate all applications, but only short-listed candidates will be contacted.

Manpower Bulgaria has License № 2033/20.04.2016 for providing human resources services