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
Location: Sofia

Key responsibilities:

• Preparation of a variety of cover letters and other correspondence for the relevant institutions;
• Fulfilling of a variety of application forms, notifications and other documentation for the relevant authorities;
• Preparation of documentation regarding drug pricing and reimbursement in Bulgaria;
• Preparation of local documentation for placing Food supplements & Medical devices on the Bulgarian market;
• Providing support in preparation of various regulatory files, including short translations;
• Preparation of references, reports and other materials for internal use;
• Communication with all concerned stuff;
• Submission of documents to the Competent Authorities;
• Communication with the Competent Authorities.

The ideal candidate will have:
• University degree or in process of obtaining (pharmacy, medicine or life science);
• Fluent English, both written and spoken;
• Strong knowledge in concepts of grammar and punctuation in both Bulgarian and English;
• 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.

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