Be a part of our growing company!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice! PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. We specialize in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.
We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. In Sofia we are looking for a Manager Regulatory Affairs.
Regulatory Affairs Manager
- Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.) worldwide;
- General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling
- Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling);
- Communication with the client and the Health Authorities;
- Training and supervising of new and/or junior colleagues;
University degree in pharmacy or other natural sciences;
- At least 3 years of professional experience in drug licensing with a focus on EU or with admission procedures in non-EU countries and experience with Launch Management, Labelling Management, Clinical Trial Applications and admission procedures in non-EU countries;
- Sound knowledge of current drug and regulatory requirements (EU);
- Structured, analytical, systematic and independent manner;
- Ability to manage internal and external (client) relationships on operational as well as clients team lead level;
- Experienced user of the MS-Office package, Adobe Acrobat and database systems;
- English language fluency, written and spoken;
- Opportunity to conquer exciting and varied challenges alongside a talented team;
- Business interaction with nearly all branches of the company across 5 continents;
- Broad range of initiatives for personal development and professional training.
If you are interested to take up the challenge at our future-oriented company, and would like to grow together with us, apply by sending your CV and Cover Letter (optional). We appreciate all applications but will be able to contact only the short-listed candidates. Thank you!