We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
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 conquier exciting and varied challenges alongside a talented team
- Flexible working hours
- Open and collaborative organisational 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 in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.