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 Regulatory Affairs Specialist
As a part of our Regulatory Affairs team, your duties will primarily include the support to management of assigned clients and projects. You will operate within local and multinational Regulatory Affairs teams, collaborating with colleagues and clients. This includes the following duties:
- Participation in regulatory processes to gain and maintain local and European marketing authorizations
- Support in preparation of documents within the framework of regulatory affairs projects (procedures, renewals, variations) in agreement with projects leads
- Support in project work (e.g. compilation, preparation and reviewing of documents)
- Provide on-site regulatory support to PharmaLex client
- Communication with the client and the Health Authorities in agreement with Line Manager
- University degree in Pharmacy or other natural sciences
- 2 to 5 years of proven experience in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects
- Ability to implement tactical goals of customer or internal projects within daily work
- Structured, analytical, systematic and independent manner
- Capability of supervision, prioritization and processing of parallel projects and tasks
- High service orientation
- Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
- English language fluency, written and spoken
- International exposure
- On-site + smart-working
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.
For further information please don’t hesitate to contact us:
Ms Laura Escabias
Senior European Recruitment Specialist
Agencies only by prior agreement for the specific job opportunity.