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Junior Regulatory Affairs Specialist

0-1 years
Not Disclosed
10 June 27, 2025
Job Description
Job Type: Hybrid Education: 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 – Gdansk, Poland

Work Model: Hybrid | Afternoon Shift | Fresh Graduates Welcome


Job Summary:

Cognizant is hiring a Junior Regulatory Affairs Specialist to support one of the world’s leading pharmaceutical companies. This hybrid role based in Gdansk is perfect for fresh graduates or early-career professionals looking to enter the pharmaceutical industry. You will play a vital role in regulatory documentation, dossier publishing, and compliance support, contributing to the full lifecycle of drug product approvals—from development to post-market surveillance.


Key Responsibilities:

  • Perform global regulatory submission and dossier publishing activities

  • Compile and maintain regulatory documents in the client’s internal repository

  • Format documentation using publishing tools (bookmarks, hyperlinks, file optimization)

  • Conduct peer reviews and support regulatory operations

  • Interact with stakeholders to ensure high-quality regulatory documentation

  • Follow internal processes and work instructions with strict adherence to guidelines

  • Support additional regulatory activities as per business needs


Required Skills & Qualifications:

  • Degree in Life Sciences, Computer Science, Engineering, Maths, or Economics

  • Computer literacy and ability to work with document management systems

  • Strong communication skills in English (verbal and written)

  • High attention to detail and analytical thinking

  • Basic knowledge of regulatory processes and documentation standards

  • Fresh graduates and early-career professionals are encouraged to apply


Perks & Benefits:

  • Competitive salary with afternoon shift allowance

  • Hybrid work model with a great office in Gdansk

  • Private healthcare, Multisport card, and more wellness benefits

  • Five-star training and learning opportunities

  • Role tailored for both personal and professional growth

  • Diverse, multicultural work environment in a global organization


Company Description:

Cognizant is a global leader in digital transformation and healthcare consulting, serving top pharmaceutical clients. With a strong presence in Poland, Cognizant empowers professionals to grow in a collaborative, high-performance environment, delivering compliance-driven innovation to the life sciences industry.


Work Mode: Hybrid (Afternoon Shift, Gdansk Office)


Call-to-Action:

Kickstart your pharmaceutical regulatory career with a global leader. Apply now for the Junior Regulatory Affairs Specialist role in Gdansk and become part of Cognizant’s mission to shape the future of healthcare through innovation and compliance.