Regulatory Affairs Manager

DRILL B.S. spol. s r.o.

Place of work
Bratislava
Contract type
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.

Employee perks, benefits

• working for stabile original company, one of the leaders
• company car for private purpose
• many other benefits

Company on whose behalf the position is being filled

Other unlisted areas

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)

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

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.

Number of employees

50-99 employees
ID: 3185787  Dátum zverejnenia: 12.9.2017