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Regulatory Affairs Manager
DRILL B.S. spol. s r.o.
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
For our klient, 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.
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
• company car for private purpose
• many other benefits
Company on whose behalf the position is being filled
Other unlisted areas
Original pharmaceutical company
Original pharmaceutical company
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
advantage: Pharmacy/Chemistry/Biology
Language skills
English - Upper intermediate (B2)
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
• 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
Advertiser
Brief description of the company
Personnel agency specialized in the field of recruitment & executive search.
Our other business activities are concentrated in three main areas:
* Comprehensive HR Solutions;
* Training & Profesisonal development;
* Professional Services & Management Consulting.
The company is a holder of a licence to offer recruitment services.
Our other business activities are concentrated in three main areas:
* Comprehensive HR Solutions;
* Training & Profesisonal development;
* Professional Services & Management Consulting.
The company is a holder of a licence to offer recruitment services.
Number of employees
50-99 employees
ID: 3185787
Dátum zverejnenia: 12.9.2017
2017-09-12
lokalita: Bratislava Pozícia: Regulatory Affairs Manager, Regulatory Affairs Specialist Spoločnosť: DRILL B.S. spol. s r.o.