Regulatory Affairs Associate

Regulatory Affairs Associate
June 21, 2022 admin

A little about Nordic Pharma:

Nordic Pharma is a mid-size privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Nordic Pharma’s expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, Nordic Pharma has a range of highly specialized proprietary and inlicensed products in the following therapeutic areas: Rheumatology, Women’s Health and Critical Care (Anaesthesia, Haematology, Oncology).

Nordic Pharma’s values of Commitment, Ambition, Respect, Reliability, Integrity and Agility describe our culture and standards and guide us in our way of working.

 

JOB TITLE: Regulatory Affairs Associate

DEPARTMENT: Corporate Regulatory Affairs Department

REPORTING TO: Regulatory Affairs Manager

DIRECT REPORTS (IF ANY): n/a

LOCATION: Hoofddorp, the Netherlands

 

General summary of role:

This is an exciting opportunity for a Regulatory Affairs Associate to join an international company with a presence in 20 countries and modern office in Hoofddorp.

You will be joining a tight-knit team of 7 employees based in France and the Netherlands. The Corporate Regulatory Affairs Department is in charge of a portfolio of 188 drug marketing authorizations (products registered in more than 28 European countries via centralized MRP, DCP and international procedure) and is recruiting a Regulatory Affairs Associate.

The Regulatory Affairs Associate will work in close cooperation with a Regulatory Affairs Manager to support in various activities required for the management of these drug marketing authorizations.
This opportunity would suit to a university graduated in pharmaceutical or medical science, a fluent English speaker, having rigorous skills and with a strong appetence in regulatory matters and in solving issues.

This position is already open and will be based in The Netherlands.
Nordic Pharma will consider candidates currently based in the EU, however candidates without an EU work permit will not be considered (if this applies to your region).


Essential responsibilities and tasks:

Under the supervision of a Regulatory Affairs Manager in charge of several therapeutic areas, you will ensure the following actions for several marketing authorizations (MA) registered in Centralised Procedure, Decentralised Procedure and National Procedures:

  • Preparation of content, eTCD sequences publishing, submission, monitoring of MA related dossiers and maintenance of these dossiers for EU and outside EU (variations, PSURs, renewals, answers to questions and requests from supervisory authorities) in order to ensure compliance with regulatory expectations and strategy defined by the company,
  • Management of regulatory change control,
  • Compilation of the IMPD for clinical dossiers,
  • Update of the common annexes (SmPC, patient leaflet and labelling) and the corresponding mock-ups of drugs and medical devices and their adequate dispatch,
  • Check the compliance of corporate promotional materials (internal documents, website…),
  • Participate in the creation, update and review of regulatory training,
  • Participate in the European regulatory intelligence for health products (drugs, medical devices and in vitro diagnostic medical devices),
    Participate in the creation, updating and revision of regulatory standard operating procedures.

 

 

Qualifications, experience and skills required:

Studies: Bachelor in pharmaceutical sciences or medical sciences.

Experience: previous experience in regulatory affairs (an added value for the position). A good knowledge of MAs files and medical products registration procedures will be appreciated.

Competences: rigorous, dedicated, autonomous, enjoy facing and solving issues, good relational skills, enjoy working within an international oriented team.

Skill: fluent in professional English (both spoken and written), French/Dutch is optional.

Hoofddorp, The Netherlands

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