Regulatory Affairs

1 week ago

Copenhagen, Copenhagen, Denmark Hurecon Full time
Regulatory Affairs - National & EU procedures

Hurecon Copenhagen, Capital Region of Denmark, Denmark

REGULATORY AFFAIRS – EU PROCEDURES - NORDIC LANGUAGE - REMOTE POSSIBLE

DO YOU WANT:

  • To use either your Danish, Swedish or Norwegian Language - together with your English language skills?
  • To have the ability to work remote as your other colleagues within RA are located in France?
  • To be a part of a well-established company managing MA authorizations in EU
  • A very broad and versatile job, spiced with both larger projects and routine assignments
  • To be part of a global team with headquarters in France, and a smaller interdisciplinary team based in Denmark
  • Contact person to authorities of European products
  • Full lifecycle management of EU procedure lifecycle from EU application to national implementation.

YOUR TASKS WILL INCLUDE:

  • Maintain and follow up on global Marketing Authorizations on the European Market
  • Manage a product's lifecycle from application submission to national package level in collaboration with different contact persons
  • Procedural contact person to authorities
  • Preparation of the administrative sections (Module 1)
  • Compilation of dossiers using document and submission management tool
  • Communicate outside the organization on behalf of the company with National Competent Authorities and company customers; ensure that relevant information is shared internally
  • Ensure correctness and grant "approval" of packaging and promotional materials
  • Keep up-to-date with changes in regulatory legislation and guidelines

YOU ARE/HAVE:

Professionally:

  • Some years of experience in Regulatory Affairs within the pharmaceutical industry, and experience with document and submission management will be a plus
  • Fluently in written and spoken English and one of the Nordic languages

Personally:

  • A will and drive to manage both smaller and larger assignments and projects alone and in collaboration with both colleagues and clients
  • Responsible, detail-oriented, and possess coordination skills
  • Team-oriented and also capable of working independently
  • Keen on working in an international environment within a well-established company with a flat organization

Little about the company:

The company in Denmark is a small department. It is a company in a Group focused on the Pharmaceutical business. Own research & development as well as regulatory infrastructure enable the development of a complete product range of injections, oral and dermatological specialties focusing on hormone and oncology products.

The company owns a large number of marketing licenses in most of Europe and distributes products worldwide, either directly or through license agreements with leading companies within the generic industry.

The company concept is to offer a complete service to its customers, from patent development to delivery of the finished product to the customer's warehouse, and to focus on the development of strategic generic products.

Application:

External consultant, Hurecon, participates in the recruitment. Please send your application to Margaret Petersen from Hurecon at mail You are very welcome to call Margaret on cell 20495451

Seniority level

Associate

Employment type

Full-time

Job function

Other, Legal, and Administrative

Industries

Pharmaceutical Manufacturing

#J-18808-Ljbffr

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