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 are specialized 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 Operations
Manager Regulatory Operations
► Project management in the field of Regulatory Operations, including preparation of proposals, project planning and tracking, communication with clients and authorities;
► Implementation of strategies for electronic submissions in the course of regulatory procedures for medicinal products (human and veterinary) and medical devices;
► Support consulting for clients concerning implementation and optimization of electronic submissions and document management systems;
► Creation, compilation and validation of electronic submissions (e.g. eCTD, NeeS) for all types of regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals) in ICH and non-ICH-areas using available software;
► Quality assurance in the field of Regulatory Operations (e.g. preparation of SOPs and WIs and corresponding training);
► Support planning, preparation, execution and tracking of projects in the context of Regulatory Information Management, incl. XEVMPD- and IDMP-related topics
► University degree in pharmacy or other natural sciences
► At least 2 years of professional experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on Regulatory Operations aspects;
► 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
► 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 (optional). We appreciate all applications but will be able to contact only the short-listed candidates. Thank you!