Junior Regulatory Affairs Specialist

Cognizant; Województwo pomorskie; Hybrid; PLN 40,000 - 60,000; Full time

Job summary

A global technology company in Poland is seeking a Junior Regulatory Affairs Specialist to manage documentation through the drug product lifecycle. The role offers a hybrid work model with flexible shifts and a supportive environment for professional growth. Ideal for recent graduates. Benefits include competitive salary and private healthcare. The position is located in Gdansk.

Benefits

Great working atmosphere

Flexible working hours

Competitive salary and benefits

Private healthcare

Multisport card

Qualifications

• Degree in Life Science, Computer Science, or a relevant field.
• Experience in the Pharmaceutical or Medical Device industry is beneficial.

Responsibilities

• Global regulatory submission/dossier publishing.
• Compile and maintain regulatory documentation.
• Perform file formatting using provided software.
• Conduct peer reviews and support regulatory activities.
• Interact with stakeholders for report quality control.
• Follow established processes and procedures.

Skills

Computer literacy

Excellent verbal and written communication skills

Demonstrated ability to be an innovative and creative thinker

Technical skills

Analytical skills

Readiness to work with databases

Knowledge of Regulatory processes and related tools

Education

Life Science, Computer Science, Engineering, Maths, Economics

Job description

Overview

Work model: hybrid, morning/afternoon shift

Location: Gdansk, Poland

Who is Cognizant?

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 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. Apply and Be Cognizant!

What Client will you be supporting?

While employed by Cognizant, you will support one of the world's largest pharmaceutical companies, with 146 affiliates and more than 47,700 employees worldwide. The company's key areas of interest are respiratory diseases, metabolism, immunology, oncology, and diseases of the central nervous system. The client operates in the fields of human pharmaceuticals, animal health, and biopharmaceuticals, and is 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

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

Essential skills

• Computer literacy
• Excellent verbal and written communication skills
• Demonstrated ability to be an innovative and creative thinker
• Technical skills
• Analytical skills
• Readiness to work with databases
• Knowledge of Regulatory processes and related tools - will be an advantage

Operational responsibilities

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

What we offer

• Great working atmosphere
• Flexible working hours: choose between morning or afternoon shifts
• Opportunity to be part of a fast-growing, well-known global company
• A role that allows you to grow both, professionally and personally
• Diverse and international work environment
• Excellent location and office space
• Competitive salary and benefits, including private healthcare, a 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.