Regulatory Affairs Publishing Expert

5 dni temu


Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

At ManpowerGroup Sp. z o.o., we are a global leader in the employment industry, operating in 82 countries and serving clients across various industries.

Job Overview

We are seeking a Regulatory Affairs Publishing Specialist to join our team, who will be responsible for executing electronic publishing of regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD format.

Key Responsibilities
  • Navigating through systems and tools to assemble, publish, validate, dispatch, and archive complex submissions according to internal processes and regulatory guidelines.
  • Providing technical support and/or guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies.
  • Maintaining open, timely, and effective communications with all publishing contributors and responsible regulatory affairs professionals.
Requirements
  • Proficient use of Regulatory Information Systems, planning, and/or publishing tools.
  • Degree in pharmacy, bioscience, or similar fields would be an asset.
  • Experience in regulatory, medical, or pharmaceutical fields, or a background in information/library science.
  • Expert level knowledge of and experience with various submission and application types, publishing templates, and relevant regulatory agency and industry guidelines.
  • Project or submission management skills.
  • Fluency in English.
  • Ability to work or lead in a matrix environment.
  • Effective interpersonal, teamwork, networking, and communication skills.
Offer
  • Opportunity to join a global team and work on innovative projects.
  • Option for 100% remote job within Poland.
  • Work mainly in English within an international team.
  • Attractive salary package.
  • ManpowerGroup Benefit Package – healthcare, sports card, insurance, professional development program.


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