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.
Regulatory Affairs Specialist
- Registration procedures for generic medicines, OTCs..., especially national ones.
- Preparation of module 1 variations (documentation, fees, CESP submission, etc.).
- Preparation of technical data sheet, package leaflet and labelling texts.
- Review of drug packaging material
- QC review of documentation, compendial cross checking and report formatting
- Ensuring that regulatory affairs programs and projects are delivered to high standards.
- Communication in the project team, with clients, local partners and representatives in the international context
- Providing regulatory expertise to regulatory programs and projects
- Professional interaction with regulatory authorities
- Accurate time reporting.
- Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
- At least 1 year of experience in Regulatory Affairs
- Knowledge of current drug and regulatory requirements (EU)
- Desirable 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
- Secure MS Excel and Word knowledge as well as confident English
- Structured, analytical, systematic thinker
- Strong communication skills
- Concentrated and high-quality work
- Ability to work in a team
- Strong sense of responsibility
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.