Specialist Regulatory Affairs

PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. The company is specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities.
Currently, PharmaLex is looking for motivated, committed candidates who will enjoy working independently within its successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then go and join the company's successful team. In Sofia PharmaLex is looking for a

Specialist Regulatory Affairs (m/f)

Your responsibilities:

- 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)

Your profile:

- Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
- At least 1 year 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.
- Solid knowledge of current drug and regulatory requirements (EU)
- First experience in a 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

Company's offer::

- Opportunity to conquier 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 PharmaLex , send your CV and Cover Letter via Jobs.bg - https://www.jobs.bg/job/4294537