Senior Regulatory Affairs Specialist / Publisher
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:
- 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
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!
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