Regulatory Affairs Specialist

On behalf of our client, a pharmaceutical company engaged in the distribution and production of pharmaceutical products, we are looking for a candidate who will successfully meet the requirements of the position: Regulatory Affairs Specialist.

Job Responsibilities:

• Supporting regional and local RA teams in West Balkans through coordination and submission of dossiers, applications for new products’ registrations and maintenance of existing products
• Achieving positive outcomes for new product registrations and variations within projected timelines
• Keeping records and files of Regulatory activities and databases
• Tracking the status of all procedures and regularly reporting to line manager
• Regularly communicating with headquarters to prioritize new procedures and upcoming changes

Position Requirements:

• University degree in Pharmacy, Bioscience, or similar field
• At least 3-year professional experience on similar positions in RA Department within the pharmaceutical industry
• In-depth understanding of regional and global regulatory requirements for pharmaceuticals
• Strong knowledge of MS Office
• Strong command of English, both spoken and written
• Adaptable and highly organized, with strong planning skills