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:
- 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
- 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
- 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
Poznaj
Cognizant Technology Solutions Poland Sp. z o.o.
COGNIZANT TECHNOLOGY SOLUTIONS POLAND SP Z O O
Cognizant is a leading IT Services provider globally, transforming Clients' business, operating and technology models for the digital era. Headquartered in the US, Cognizant is ranked on the Fortune 500 and is consistently listed among the most admired companies in the world.
At Cognizant, we celebrate diversity and inclusion across our workforce and with our partners, communities and fellow racing fans. That’s why, alongside the Aston Martin Cognizant Formula One team, we work in unison for a more inclusive future. All in, all welcome.