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Regulatory Operations Senior Manager

3 miesięcy temu

Warszawa, Mazovia, Polska Michael Page Pełny etat

About Our Client

Our client is an internashional pharmaceutical company with an established position.

Job Description

  • To be the main contact/representative for Regulatory Affairs (RA) in business initiatives/projects involving or impacting data, systems and processes (Enterprise Content Management, Product Lifecycle Maintenance, Change Control)
  • To drive business initiatives/projects involving or impacting RA data, systems and processes (Regulatory Information Management system, eCTD publishing system)
  • To ensure RA data compliance with external requirements (main focus on Europe (SPOR, PLM)), through adequate processes and systems
  • To ensure RA data are current, accurate, usable and adequately linked to the relevant systems and processes in place in the business
  • To ensure appropriate support and training are in place for the relevant RA community concerning the systems and processes in use in the business
  • To drive optimisation of the systems and processes in use in the business;
  • To create and maintain processes that enable centralised medicinal publishing within the business unit (EU) with a view to expand those processes to the wider RA Community.
  • To support equipping the Regulatory Affairs function for further digital transformation including integration of data and Artificial Intelligence solutions
  • To manage a team of Operations Administrators (currently two team members but with planned future expansion)

The Successful Applicant

  • Bachelor or Master's degree in Life Science or Information Technology
  • 8 years of experience in a relevant regulatory environment ideally part of it within an Operations role
  • Great communication skills.
  • Good project management skills.
  • 'Give it a go' and positive attitude being keen on creative and problem-solving thinking whilst being thorough and focused with attention to detail.
  • The ability to support several concurrent projects/products in a flexible manner both autonomously and in a team environment.
  • Must be collaborative and able to influence change.
  • Inclusive and customer service oriented.

What's on Offer

  • Work in hybrid model
  • Basic salary with annual bonus
  • Sport card
  • Medical care - family package
  • Company car or car allowence

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