Senior Regulatory Affairs Consultant (multiple EU locations)

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 areas we would love to hear from you!

The role can be flexibly based in several EU locations based on candidates' skills and experience.

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 / Medical devices / non-interventional experience is an added value QualificationsIdeal candidate will possess: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Extensive years of experience in a CRO or industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus Fluency at a professional level in Romanian and English language High-level consulting skills Critical thinking and problem-solving skills Project leadership and management knowledge Excellent interpersonal and intercultural communication skills, both written and verbal Client-focused approach to work If you have the required experience we encourage you to apply, you will be rewarded with a competitive salary and benefits package!