Senior Regulatory Affairs Specialist

2 miesięcy temu

Gdańsk pomorskie, Trójmiasto, Polska Cognizant Technology Solutions Poland Sp z o o Pełny etat
Shift: 9 AM- 5 PM / 3 PM - 11 PM
Work model: hybrid

What we do


As Top Employer, we are dedicated to helping the world's leading companies build stronger businesses — helping them go from doing digital to being digital.


Cognizant Poland 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





What Client will you be supporting?


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 a Senior Publisher, you will provide support to all regulatory-related activities as per the business requirements.


Essential skills and qualifications:

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 the pharmaceutical industry and submission publishing requirements globally,
Experience with electronic document management systems, publishing tools, knowledge of document publishing,
Excellent verbal and written communication skills,
High level of organizational awareness,
Previous experience in being a quality checker and trainer or mentor.

Operational Responsibilities:

Being 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, and complex submissions ensuring adherence to internal and external document standards,
Interacting with relevant stakeholders during the preparation and quality control of reports and regulatory documentation,
Providing support to other regulatory-related activities as per the business requirements.
What we offer:

Extensive benefits package: Multisport Card, LuxMed medical healthcare including dental care, life insurance, cafeteria benefits,
Open-minded and multinational environment,
Opportunity to be part of a global organization focused on development,
Professional development and a clear career path,
Training & development opportunities including language courses.
Working from home scheme,
Possibility of morning and evening shifts.

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