Expert - Regulatory Affairs Publishing

At Cognizant, we are dedicated to helping the worlds 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 worlds largest pharmaceutical companies, operating with 146 affiliates worldwide. The Companys 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.

• Previous experience in electronic submission publishing, dossier management and dispatch of regulatory dossiers (US, EU, Asia, Latin America, etc.),
• Previous experience in publishing complex, major submissions, publishing modules 3,4,5,
• Strong knowledge of Regulatory processes within pharmaceutical industry and submission publishing requirements globally,
• Experience with electronic document management systems, publishing tools, knowledge of documents publishing,
• Excellent verbal and written communication skills,
• High level of organizational awareness,
• Previous experience in being quality checker and trainer or mentor.

• Being a first level support and guiding Juniors to compile regulatory documentation with 100% quality targets met and solve validation errors,
• Performing technical quality control of dossier documents, complex submissions ensuring adherence to internal and external document standards,
• Interacting with relevant stakeholders during preparation and quality control of reports and regulatory documentation,
• Providing support to other regulatory related activities as per the business requirements.

• 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,
• 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.