Expert - Senior Regulatory Affairs Publishing

What we do:

At Cognizant, we are dedicated to helping the world's leading companies build stronger businesses - helping them go from doing digital to being digital.

In Poland, our offices are located in Gdansk, Wroclaw, and Kraków. With the capacity to support various clients, we offer a world of opportunities for both professionals and graduates.

You can expect five-star training, a chance to realize your career goals, and a range of benefits.

Be Cognizant!

While employed by Cognizant, you will be supporting one of the world's largest pharmaceutical companies, operating with 146 affiliates worldwide. The Company's key areas of interest are respiratory diseases, metabolic diseases, immunology, oncology and diseases of the central nervous system. The Client works in human pharmaceuticals, animal health, and biopharmaceuticals. The Company is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

As an Expert Publisher you will provide support to all regulatory related activities as per the business requirements.

• Science, computer science or engineering degree
• More than 4 years of 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 within pharmaceutical industry (incl. different submissions procedures)
• Excellent verbal and written communication skills
• 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

• First level support in case of questions or issues within the team for the process and the tools used to perform the task
• Nominated trainer / BI certified process trainer for on-the-job trainings
• PoC for the BI Process Owners/SME in case of process and tool changes and troubleshooting
• HUB representative in cross-location initiatives and knowledge sharing
• Authoring and reviewing process and project related documentation.
• Coordinates subprojects as required
• 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 including global regulatory submission / dossier publishing, day-to-day activities and deliverables
• Ensuring Training & compliance to applicable CTS and BI "Quality Management System

• Working from home scheme,
• Great working atmosphere,
• Possibility of morning and evening shifts,
• Opportunity to be part of a fast-growing, well-known global company,
• Role that allows you to grow both, professionally and personally,
• Diverse and international work environment,
• Excellent location and office space,
• Extensive benefits package: Multisport Card, Lux Med medical healthcare including
• dental care, life insurance, cafeteria benefits.