Regulatory affairs manager (specialist)

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

Place of work
Contract type

Information about the position

Job description, responsibilities and duties

• Responsibility for a part of portfolio
• Timely, in good quality and properly documented submission of all registration processes (new submissions and life cycle mamagement)
• Ensure high quality translations of product information
• Ensure regulatory compliance
• Contribute to the good company image
• Building and maintaining professional relationship with the local Health Authorities
• Timely update of internal and external databases and documents
• Support global functions and cooperation with other functions in the local level
• Adherence to the global and local Standard Operating Procedures and Operational Manuals

This position is a maternity-leave substitition (till cca 5/2019)
Position is without direct subordinates.

Employee perks, benefits

• work for well-known original pharmaceutical company
• professional development
• attractive package of benefits

Company on whose behalf the position is being filled

Other unlisted areas

Well-known 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)

Language skills

English - Upper intermediate (B2)

Personality requirements and skills

• Experience on Regulatory affairs position
• An appropriate education (preferably medical, pharmaceutical, biological science backround)
• Fluent English
• MS Office
• Dynamic, responsible and highly self-motivated individual, able to work and deliver under pressure
• Excellent communication skills and a sound understanding of customer needs
• Person with a high degree of social competence, who enjoys teamwork
• Flexible and customer oriented person


Brief description of the company

Our core business activities are concentrated in three main areas:
* Comprehensive HR Solutions;
* Outsourcing of Support Functions and Service Units;
* Professional Services & Management Consulting.

The company is a holder of a licence to offer recruitment services.

Number of employees

50-99 employees

Company address

DRILL B.S., spol. s r. o.
Jakubovo námestie 13
811 09 Bratislava
ID: 2806690   Dátum zverejnenia: 10.11.2016