Senior Consultant, Regulatory Affairs - Regulatory Lead

Parexel International Corporation

Milan, Lombardy, Italy

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 / Medical devices / non-interventional experience is an added value QualificationsAcademic Qualifications and Experience Required:

- 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

- 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

- Results orientation

- Teamwork and collaboration skills

- Fluency at a professional level in Italian and English language

If you have the required experience we encourage you to apply, you will be rewarded with a competitive salary and benefits package!

2021-05-03 00:05:22

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