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.
Specialist, Regulatory Affairs
- Support with preparation of documents within the framework of regulatory affairs projects European (CP, MRP, DCP, renewals, variations, and country-specific procedures) and non-European in agreement with projects leads
- Support with project work (e.g. compilation, preparation and reviewing of documents) after adequate instruction
- Support with preparation and handling of internal and external correspondence
- Technical organization of training sessions, meetings, client visits etc. (e.g., room booking, setup and operation of presentation equipment)ç
- Maintain internal departmental templates
- Assist the project manager in project planning and organization.
- Assist the heads of regulatory department and regulatory affairs teams.
- Basic experience in technical area of expertise
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- IT comprehension
- Comprehension of technical process areas and quality assurance
- Knowledge on databases and structure of databases
- Knowledge regarding regulatory guidelines for European procedures and rest of the world
- Knowledge on networking of authorities (databases)
- Ability to analyse and solve problems and to develop possible solutions
- Ability to motivate teams and simultaneously manage several projects
- Ability to represent the company towards externals
- Good communication skills (written and verbally); capability to point out issues and providepotential options for solution in the area of expertise. Confident appearance.
- Fluent Portuguese and English skills
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.
Agencies only by prior agreement for the specific job opportunity.