Regulatory Database Manager

Nordic Pharma

Regulatory Database Manager

Nordic Pharma

Amsterdam or Paris

Do you want to be part of the success of an organization that addresses unmet medical needs?

What are you capable of? Who are you? These questions always follow each other at Nordic Pharma. We find important that who you are as a person matches with us as an organization.

Especially in terms of your values & working style. A professional at Nordic Pharma is not just any professional. Autonomy. Integrity. Rigor. Agility. Driven. That is how our clients know us.

We are looking for an international Regulatory Database Manager to join the Corporate Regulatory Affairs Department. You would join an international team of 8, based in France and in the Netherlands, currently in charge of a portfolio of 188 MMAs (products registered in more than 28 European countries via centralized MRP, DCP and international procedure).

The position is based in either Amsterdam area (Netherlands) or Paris (France), with a preference to having you in Amsterdam area.

Your Responsibilities:

In collaboration with the Regulatory Affairs Managers, you will be key in managing the administrative actions and the Regulatory database. Your responsibilities will consist of:

  • Guaranteeing the compliance of the Group MAs portfolio information in the department database (RIM), by ensuring:
    • Entry and updating of product/activity related information;
    • Regular data integrity/QC checks on the data;
    • Submissions according to article 57 – xEVMPD/IDMP, processing of the (3rd) ACKs;
    • Development and improvements to the system;
    • Management of the access authorizations;
    • Users training and up to date work instructions;
    • General communication with the database supplier;
    • Keeping track of developments in the esubmission field.
  • Collaborating to the activities of MAs registration and update: filling the application forms, managing the payment of administrative fees, managing the CPP and legalization requests;
  • Managing the packaging items supplier;
  • Planning and evaluating according to the department budget.

Your Profile:

  • You have at least a Bachelor of Science, preferably a Masters;
  • You already have a proven track record of 2-3 years working as a Database Manager;
  • You already have a good knowledge of Mergers and Acquisitions file processing and medical products registration procedures together with experience in the database validation or in a clinical environment;
  • You are agile and knowledgeable of the newest digital technologies that could make our processes more efficient.

Your Values and Working Style:

  • High standards. You expect personal performance and team performance to be nothing short of the best;
  • Honesty/Integrity. You don’t cut corners ethically. You earn trust and maintain confidence;
  • Excellent work ethic. You know your team relies on you and you take pride in that;
  • Rigor. You pay attention to details, you do your due diligence and find efficient ways of conducting your tasks;
  • Autonomy. You don’t need micromanaging. You enjoy solving challenges, taking initiatives and you are not afraid to ask for support when you need it;
  • Excellent interpersonal skills. You will be working with multiple stakeholders in an international environment, so your cultural agility and the skill of creating rapport with others are crucial for the success of this role.

You would like to make a difference and join a company dedicated to unmet medical needs?

Please send your CV and covering letter to: sanne.rietveld@kennedyfitch.com.

Don't forget to mention EuroPharmaJobs when applying.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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