Temat: Regulatory Affairs Specialist Poland Warsaw-Start July 2010

--Fix Term Contract 9 months-- Maternity Cover--Start July 2010
8000PLN to 10000PLN Monthly depending on experience
Our client is a global player in the field of health care. Its leading position is extended continuously by an innovative portfolio of medicines and the highly motivated and qualified team.

For the office in Warsaw we are looking for a competent, motivated:
Regulatory Affairs Specialist (m/f)
Principle Responsibilities
Provide regulatory guidance and support to RAST Team
Provide regulatory input to ensure acceptable labeling in no CEE/CIS markets
Establish/Maintain close working relationship between ERA and CEE/CIS colleagues
Ensure that regulatory management systems are employed to record day to day regulatory activities
Candidate Profile
A Good academic background with experience in Regulatory Affairs
Awareness of European Regulatory Procedures (MRP, DCP, CP) and regulatory procedures in non EU CEE/ CIS countries
Demonstrate excellent leadership and organizational skills to manage a multitude of countries and an effective liaison between European Regulatory Affairs and CEE Regulatory staff
Fluency in Polish and Good English preferably
Excellent negotiation and influencing skills
Capable to work in a matrix structure in a challenging environment
Positive work style, approachable, flexible and accountable
Attention to detail with analytical mind enabling assimilation of complex issues into a logical and presentable format
Balanced personality remaining calm under pressure and who is able to make decisions
Readiness to travel
IT literate and able to work with document management systems and databases
Please show your interest by contacting me on below email address
jacek.korona@hayspharma.com