Deputy Responsible Person for Distribution/Regulatory Affairs Manager

Location
Prague
Salary
Competitive
Posted
Oct 06, 2022
Closes
Oct 28, 2022
Ref
3568
Function
Management
Industry
Science
Hours
Full Time
Deputy Responsible Person for Distribution / Regulatory Affairs Manager

Prague - Czech Republic

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

This position is a combination of a back-up of our Responsible Person for Distribution who ensures the wholesale distributor's compliance, and a Regulatory Affairs Manager, who covers submissions of clinical studies/clinical investigations to the local regulatory/health authorities and ethics committees.

Responsibilities
  • To ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met;
  • To assist, coordinate, manage and track the submission of clinical studies/clinical investigations to the local
    regulatory/health authorities (RA) and ethics committees according to the Client requirements, NEOX/Client SOPs,
    local legislation and regulatory requirements;
  • To assist, coordinate, manage and track activities related to obtaining and maintenance of marketing
    authorization of the medicinal product including liaison with RA and third parties.

Experience
  • Bachelor's or University Degree in health, clinical, biological, chemical or mathematical sciences, or related field.
  • Experience in the pharmaceutical industry an advantage.
  • Fluent in English, both written and verbal.

We offer
  • 25 vacation days.
  • Friendly and collaborative working environment.
  • Flexible working hours.
  • Training in Data management.
  • Opportunity to acquire new skills and knowledge.


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