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Senior Regulatory Affairs Specialist

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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 Gdańsk, Wrocław, 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 an Expert 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,

For more information about us, visit Cognizant Poland.

If you are looking for another opportunity and are interested in the company, do not hesitate to apply online!

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We are an equal-opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

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The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.

  • Cognizant is a global community with more than 345,000 associates around the world.
  • We don’t just dream of a better way – we make it happen.
  • We take care of our people, clients, company, communities and climate by doing what’s right.
  • We foster an innovative environment where you can build the career path that’s right for you.

About us:
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, helping organizations modernize technology, reimagine processes and transform experiences so they stay ahead in a fast-changing world.

Our commitment to diversity and inclusion:
Cognizant is an equal opportunity employer that embraces diversity, champions equity and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other protected characteristic as outlined by federal, state or local laws.

Disclaimer: 
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

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