Regulatory and Medical Affairs Specialist

Alkaloid AD Skopje is a company which eight decades, has been operating in the field of manufacturing drugs, cosmetic and chemical products and processing botanical raw materials.
Alkaloid AD is a joint stock company that consists of two profit centers: Pharmaceuticals and Chemicals, Cosmetics and Botanicals; There are two subsidiaries in the country as well as 14 subsidiaries and 4 representative offices abroad (in Serbia, Montenegro, Kosovo, Albania, Bosnia and Herzegovina, Croatia, Slovenia, Switzerland, Bulgaria, Turkey, Ukraine, the Russian Federation, and the USA).
The Representative office of Alkaloid AD Skopje in Bulgaria is looking to hire a fast learner to join the Regulatory team as

Regulatory and Medical Affairs Specialist

Key responsibilities:

• Preparation of a variety of cover letters and other correspondence for the relevant institutions;
• Support submissions and follow-up procedures with the competent authorities (Ministry of Health, Bulgarian Drug Agency, National Council on Pricing and Reimbursement, Bulgarian Food Safety Agency);
• Preparation of documentation regarding drug pricing and reimbursement in Bulgaria;
• Preparation of local documentation for placing Food supplements & Medical devices on the Bulgarian market;
• Translation and editing various regulatory files;
• Preparation of references, reports and other materials for internal use;
• Submission of documents to the Competent Authorities;
• Communication with the Competent Authorities.
• Continuous following of EU and national legislation and requirements.

• Preferably Pharmacist (MSc), Life sciences degree (BSc or equivalent) also acceptable;
• Excellent written and oral communication skills in English are required;
• Ability to be diligent and detail oriented;
• Good organizational and communication skills;
• Previous work experience in Regulatory Affairs would be considered as an advantage;
• Very good knowledge in MS Office.
• Multitasking ability to follow-up projects, monitor and stay within deadlines is a distinct advantage.

We offer:
• Being part of a successful business;
• Dynamic and challenging job in an international environment;
• Regular training on national and international level.
• Professional development.

Please apply via - or send your detailed CV in English, motivation letter and references (if available) to Sofia 1404, 2 Rikardo Vakarini Str, fl. 3, apt. 10, Alkaloid Ltd