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Junior Regulatory Affairs Specialist
  • Gdańsk
Junior Regulatory Affairs Specialist
Gdańsk, Gdańsk, Pomeranian Voivodeship, Polska
Cognizant
25. 2. 2025
Informacje o stanowisku

Work model: hybrid

Who is Cognizant?

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 based in Gdańsk, Wrocław, and Kraków. With the capacity to support various clients, we offer a world of opportunities for professionals and graduates. You can expect five-star training, a chance to realize your career goals, and a range of benefits.

What Client will you be supporting?

While employed by Cognizant, you will support one of the worlds largest pharmaceutical companies, with 146 affiliates and more than 47,700 employees worldwide. The companys key areas of interest are respiratory diseases, metabolism, immunology, oncology, and diseases of the central nervous system. The client works in human pharmaceuticals, animal health, and biopharmaceuticals and is also a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

As a Junior Regulatory Affairs Specialist, you would review the documentation that covers the whole lifecycle of a drug product – from the development, through clinical trials, to its first approval in the market, and beyond – an exciting professional opportunity in the world of pharmacovigilance!

Essential Qualifications

  1. Life Science, Computer Science, or any other degree that supports strong analytical thinking (Engineering, Maths, Economics).
  2. Experience in the Pharmaceutical industry, Medical Device industry, or any related industry, or relevant experience in Regulatory Affairs, will be an advantage but not essential.

Essential Skills

  1. Computer literacy.
  2. Excellent verbal and written communication skills.
  3. Demonstrated ability to be an innovative and creative thinker.
  4. Technical skills.
  5. Analytical skills.
  6. Readiness to work with databases.
  7. Knowledge of Regulatory processes and related tools - will be an advantage.

Operational Responsibilities

  1. Global regulatory submission/dossier publishing - daily activities and deliverables.
  2. Compilation and maintenance of regulatory documentation as per the procedure in the client repository.
  3. Performing high level of file formatting using provided software (creating bookmarks, hyperlinks, file optimization, etc.).
  4. Performing peer-review of work and providing support to other regulatory-related activities according to business requirements.
  5. Interacting with relevant stakeholders during the preparation and quality control of reports and regulatory documentation.
  6. Following established processes and procedures, adhering to the Client’s work instructions and procedures.
  7. Achievement-building orientation.

What We Offer

  1. Great working atmosphere.
  2. Afternoon shift with shift allowance.
  3. Opportunity to be part of a fast-growing, well-known global company.
  4. Role that allows you to grow both, professionally and personally.
  5. Diverse and international work environment.
  6. Excellent location and office space.
  7. Competitive salary and benefits such as private healthcare, multisport card, and more.

FRESH GRADUATES ARE WELCOME!

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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