Regulatory Affairs Manager

Up to €100,000
09 Feb 2021
11 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

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

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