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Junior Regulatory Affairs Specialist

2+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: BCS/B.Tech/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Junior Regulatory Affairs Specialist

Work Model: Hybrid


Who is Cognizant?

Cognizant is dedicated to helping the world's leading companies transition from doing digital to being digital. In Poland, we have offices in Gdańsk, Wrocław, and Kraków. We offer world-class training, diverse career opportunities, and a range of benefits for both professionals and graduates.


About the Client:

You will support one of the world’s largest pharmaceutical companies, known for its commitment to respiratory diseases, metabolism, immunology, oncology, and central nervous system disorders. The company operates globally with 146 affiliates and over 47,700 employees, and is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). As a Junior Regulatory Affairs Specialist, you will work with documentation throughout the full lifecycle of a drug product—from development and clinical trials to market approval.


Essential Qualifications:

  • Degree in Life Science, Computer Science, Engineering, Maths, Economics, or similar fields with strong analytical focus.

  • Prior experience in the pharmaceutical, medical device, or related industry is advantageous but not mandatory.

  • Previous exposure to Regulatory Affairs is a plus.


Essential Skills:

  • Strong computer literacy.

  • Excellent verbal and written communication.

  • Creative and innovative thinking.

  • Technical and analytical skills.

  • Familiarity with databases.

  • Knowledge of regulatory processes and tools (advantageous).


Operational Responsibilities:

  • Daily global regulatory submission/dossier publishing.

  • Compile and maintain regulatory documents in the client repository.

  • Perform advanced document formatting (bookmarks, hyperlinks, optimization).

  • Conduct peer reviews and support other regulatory tasks as needed.

  • Coordinate with stakeholders for preparation and quality control of regulatory documentation.

  • Adhere to client work instructions and regulatory procedures.

  • Exhibit achievement-driven mindset and high-quality standards.


What We Offer:

  • Dynamic and collaborative work environment.

  • Afternoon shift with shift allowance.

  • Fast-track professional and personal growth opportunities.

  • International team with diverse perspectives.

  • Centrally located office space with excellent infrastructure.

  • Competitive salary and comprehensive benefits (private healthcare, multisport card, and more).

  • Welcoming environment for fresh graduates.


Additional Information:

If you are enthusiastic about beginning your career in Regulatory Affairs, apply online and become part of a global, innovative team at Cognizant Poland.

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Equal Opportunity Statement:

Cognizant is committed to creating a diverse work environment and is proud to be an equal opportunity employer. We do not discriminate on the basis of any legally protected status.

For accommodation requests during the application process, contact: CareersNA2@cognizant.com


Disclaimer:

Cognizant reserves the right to update compensation or job details as required by law. Candidates may be asked to verify identity during interview processes.