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 Senior Manager Regulatory Affairs.
Senior Manager Regulatory Affairs
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
Communication in the project team, with customers, local partners and representatives in the international context
Review of approval documents and text management (labelling management)
Training and supervising of new and/or junior colleagues
Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
At least 5 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)
Experience in project management, multi-task consulting environment
IT affinity to databases and the handling of project management software
Team-oriented, communicative, conscientious, accurate and responsible
Flexibility to travel
Secure MS Excel and Word knowledge as well as confident English skills
Opportunity to conquer exciting and varied challenges alongside a talented team
Flexible working hours
Open and collaborative organizational culture with emphasis on knowledge-sharing
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. We appreciate all applications but will be able to contact only the short-listed candidates. Thank you!