Senior Consultant, Regulatory Affairs - Regulatory Lead

30 Apr 2021
30 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

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
  • Qualifications

    Academic 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!Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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