Submissions Publishing Expert

4 dni temu


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

We are looking for a highly skilled Submissions Publishing Expert to join our team at ManpowerGroup Sp. z o.o.

About the Role

This position involves working on the execution of electronic publishing of moderate to complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD format.

Main Responsibilities

The key responsibilities of this role include:

  • 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.
  • Interpreting and enforcing paper and electronic regulatory submission standards, policies, and operating procedure requirements.
Qualifications

To succeed in this role, you should have:

  • 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.
  • Therapeutic area and product knowledge, in-depth understanding of product development process.
Benefits and Perks

Join our team and enjoy:

  • A dynamic and challenging work environment.
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.


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