Senior Consultant - Regulatory Affairs (Poland)
Parexel International Corporation
Warsaw, Mazovia, Poland
We are recruiting for a Senior Consultant, Regulatory affairs to Lead our Regulatory activities for Gene Therapy, Non interventional and Biosimilar trials. If you are a Regulatory Leader in either of these Therapeutic areas we would love to hear from you! We are looking for candidates in Poland, Hungary, Italy, Spain, Czech Republic or Romania
Scope of responsibilities: Regulatory Leader activities including regulatory submissions for all phases, multinational clinical studies for European and Non-EU countries (e.i. Asia-Pacific, Latin America); Single point of contact for RA submission strategy and consulting Liaison with local regulatory teams, PXL global team and the Sponsor Global regulatory intelligence Labelling consultation Biosimilar / non-interventional experience is an added value Qualifications
Requirements: Degree educated within a science based discipline At least 5 years of experience in clinical trials (from CRO / Pharma companies) Strong communication and interpersonal skills Client-focused approach to work (Quality) Regulatory Project Management/Lead experience
If you feel you have suitable experience we encourage you to apply, you will be rewarded with a competitive salary and benefits package!