Senior Regulatory Affairs Specialist / Publisher

COGNIZANT TECHNOLOGY SOLUTIONS POLAND SP Z O O

Gdańsk

5 dni temu

Our Gdansk office provides support for our Customers which include the world leaders in Pharma, Banking, Consumer Goods and Telecom.

If you want to take the opportunity to learn and grow in a multicultural, service orientated environment please get in touch with us.  We would be happy to welcome you in our team.

We are currently growing our local Regulatory Affairs team and looking for:

Senior Regulatory Affairs Specialist / Publisher
Gdańsk

 

 

As a Senior Regulatory Affairs Specialist/Publisher you will:  
  • Responsible for global regulatory submission / dossier publishing day-to-day activities and deliverables
  • Compilation and maintenance of regulatory documentation as per the procedure in client repository
  • Performing high level of files’ formatting using the client provided software (creating bookmarks, hyperlinks, file optimization etc.)
  • Performing technical quality control of dossier documents ensuring adherence to internal and external document standards.
  • Interacting with relevant stakeholders during preparation and quality control of reports and regulatory documentation
  • Providing input and advice to project on relevant aspects of the submission process
  • Supporting the client in aligning the process maps/SOPs/WI as per recent updates
  • Providing support to other regulatory related activities as per the business requirements
Basic qualifications:
  • Science, computer science or engineering degree
  • Previous experience in pharmaceutical / Medical Device / any related industry, with relevant experience in electronic submission publishing, dossier management and dispatch of regulatory dossiers (US, EU, Asia, Latin America, etc)
  • Expert in submission publishing requirements globally
  • Strong knowledge of Regulatory processes
  • Excellent verbal and written communication skills in English
  • Demonstrated ability to be innovative and a creative thinker
  • High level of organizational awareness
  • Experience with electronic document management systems, publishing tools, knowledge of documents publishing/document management
We offer you:
  • Opportunity to be a part of a rapidly expanding, well known global organization
  • Role that allows you to progress both professionally and personally
  • Diverse and multinational environment
  • Friendly and inspiring work atmosphere
  • Trainings with international specialists
  • Excellent location and office space
  • Competitive salary and benefits

If you want to apply for this job please, send us your curriculum vitae in English

by clicking on APLIKUJ TERAZ.

 

In case this offer does not match your profile but you know someone who might be interested we would be grateful for forwarding this job offer!

Prosimy o dopisanie klauzuli: Wyrażam zgodę na przetwarzanie moich danych osobowych zawartych w mojej ofercie pracy dla potrzeb niezbędnych do realizacji procesu rekrutacji (zgodnie z Ustawą z dnia 29.08.1997 r. o Ochronie Danych Osobowych; tekst jednolity Dz. U. z 2016 r. poz. 922 z późn. zm. ). Jednocześnie oświadczam, że zostałem/am poinformowany/a o dobrowolności podania danych osobowych oraz prawie dostępu do treści swoich danych i ich poprawiania.

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COGNIZANT TECHNOLOGY SOLUTIONS POLAND SP Z O O

Poznaj stanowisko: Farmaceuta

Farmaceuta jest to osoba, która wydaje leki za odpowiednią opłatą oraz sporządza leki recepturowe. Do zadań tego pracownika należy zarówno udział w wytwarzaniu leków na skalę przemysłową, jak i wykonywanie w aptece specyfików zgodnie z zaleceniami lekarza. A także musi wydawać leki za opłatą, udzielać porad dotyczących działania i stosowania leków, prowadzić dokumentację oraz monitorować działania ...
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