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.
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
- General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling
- Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
- Communication with the client and the Health Authorities
- Training and supervising of new and/or junior colleagues
- University degree in pharmacy or other natural sciences
- At least 3 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)
- 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 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 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.