Regulatory Affairs Manager

Location
Netherlands
Salary
Up to €100,000
Posted
09 Feb 2021
Closes
11 Mar 2021
Hours
Full Time
Contract Type
Permanent
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

Apply for Regulatory Affairs Manager

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs