Senior Manager Regulatory Affairs (m/f) - Bulgaria
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- Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life?
- Our company 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.
- Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as life-cycle 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