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Regulatory Affairs Manager

Employer
Barrington James
Location
Netherlands
Salary
Up to €100,000
Start date
9 Feb 2021
Closing date
11 Mar 2021

Job Details

The company

My client are a full service consultancy who support Top 10 Pharma's & innovative Biotech's globally. Working at this company is like being in an entrepreneurial start-up with the financial backing of a top consulting firm. You are are given the opportunity to stretch & learn on your own terms.

 

​Purpose of the role

  • Responsible for local regulatory activities for The Netherlands, supporting a portfolio of products (i.e., as Member State)
  • Responsible for supporting central regulatory activities for a portfolio of products registered via the Centralized Procedure (i.e., as EU/EMA contact)

Key responsibilities

  • Tracking and updating regulatory management systems and databases on a regular basis
  • Review and confirmation of submission strategy, including submission documentation requirements
  • Coordination with Central Regulatory Team for submission packages for variations, renewals, new product applications, PSURs, etc.
  • High level review of submission packages and preparation of country specific module 1 documents in English or Dutch language (as applicable)
  • Correspondence with respective Health Authorities regarding submission timelines, approvals, and responses to Health Authority queries
  • Act as a local regulatory affairs point of contact for regulatory queries from internal functions (e.g., Marketing, QA, Supply Chain, etc.)
  • Support regulatory planning process by providing local regulatory input to annual planning program
  • Distribution of Health Authority communications within the company
  • Coordination with Central Regulatory Affairs and other functions for certificates and samples for submission to Health Authorities
  • Review / approval of labelling, artwork changes, promotional material, abbreviated product information and addenda to Clinical Overviews
  • Translation activities related to labelling, artwork and other regulatory documentation as required
  • Support compliance activities (e.g., change control)
  • Ensure changes to local regulatory requirements are communicated effectively and relevant actions taken to ensure continued compliance of marketed products
  • Maintenance of products registered via the EU Centralized Procedure
  • Communication and coordination with regulatory colleagues in multiple Member States, suppliers and other third parties (e.g., translation partner, contract manufacturers, etc.)
  • Provide input on regulatory risk assessments

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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