||Our client is an innovative pharmaceutical company. In a view of supporting their further expansion on the Serbian market, Adecco is looking for dynamic and responsible candidates.
• University degree in Pharmacy, Medicine or Dentistry
• 5+ years of experience on the similar position in regulatory affairs
• Fluency in English
• PC literacy
• Ensure that all regulatory submissions in Serbia, Montenegro, Albania and Kosovo are prepared, filed and approved in a timely manner in accordance with Company Standard Operating Procedures (SOPs), policies and local regulations
• Control and follow-up general expenditures during registration activities. Budget preparation, planning and control, monthly review of expenses, budget review and follow up of investments
• Monitoring of new legislation/guidance nationally and internationally, fully understanding implications and agency expectations. Take lead to communicate impact on Company business to the WRA.
• Liaising with external authorities & trade organizations for insights into current activity, future direction of legislation, and to identify opportunity for influence of policy/legislation in line with corporate positions on key topics
• Carry out quality control and audit of the Company’s bonded stock related to the storage, use, affixing and handling of the control labels; validate and approve reports and records on affixing the labels and submit the reports on affixing the labels to the Ministry of Health and Medicinal and Agency for Medicines and Medical Devices
• Review prices on a regular basis, anticipate exchange rate revision and its potential impact, monitor reference prices and new entries in reference countries, follow-up all potential price changes
• Establish and intensify contacts with key stakeholders: representatives of the NHIF, members of the Republic Expert Committee, Pharmacoeconomics Committee and Central Committee, Ministry of Health, special interest groups, patient organizations
• Local Responsible Person for Pharmacovigilance
• Responsible person for compliance, ensures business is conducted in line with the Law, INOVIA Code and good practices of the Group
• Acting as a Contact for Medical Information
• Strong character with excellent organizational, communication and interpersonal skills
• Initiative person with an ability to work independently
• Team spirit and high ethical standards
• Capability to work under pressure in a dynamic business environment
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