Regulatory Affairs Manager (Original company)
2017-09-27
Place of work: Bratislava
For our client, original pharmaceutical company, we are looking for Regulatory Affairs Manager.
You will be responsible for:
• Managing preparation of documentation to obtain and maintain all Marketing Authorization approvals /medical devices/
• Coordinating and optimising the registration process in SK with the aim of the registration of the medical devices according to approved time schedules as part of the incorporation of the DRA requirements into the company´s internal standards
• Monitor and interpret local regulatory requirements/legislation
• Communication/negotiation with the local regulatory authorities
• Local texts preparation
• Provide regulatory assistances to support commercial activities
• Revise marketing materials also from the compliance point of view
• Local contact for the Cluster Compliance Manager
Position is without direct subordinates.
Employee perks, benefits:
• Working for stabile original company, one of the leaders
• Company car for private purpose
• Many other benefits
Personality requirements and skills:
• At least 3 years experience in Regulatory Affairs
• Fluency in English
• Communication and organisation skills
• Knowledge of the legal regulatory background (Local and EU)
• Experience in working with cross-functional teams
• Ability to work independently and prioritize tasks
Contact for sending CV and any further questions:
Peter Lazový,
Key Account Manager/Consultant
email: peter_lazovy@drill.sk
Phone: +421 911 011 575
