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Regulatory Affairs Officer – Greece

0-2 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time 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

Regulatory Affairs Officer – Greece (Full-Time, Permanent Contract)

Excelya | Full-Time | Permanent | Greece

Excelya, a leading European CRO founded in 2014, is dedicated to providing innovative clinical research solutions. With a global team of 900+ experts, we collaborate across regulatory affairs, clinical operations, and quality assurance to drive advancements in healthcare.

At Excelya, we cultivate a dynamic and growth-oriented professional environment, ensuring that our team members develop their expertise and contribute meaningfully to life-changing research.

Position Overview

We are seeking a Regulatory Affairs Officer to join our Regulatory Affairs team in Greece. This role is ideal for recent graduates or early-career professionals looking to gain hands-on experience in regulatory processes within both pharma and non-pharma industries.

Key Responsibilities

  • Assist in the preparation, review, and submission of regulatory documents (e.g., marketing authorizations, variations, renewals).
  • Support the development of product dossiers for pharmaceuticals, medical devices, and non-pharma projects.
  • Track and coordinate regulatory submissions, ensuring compliance with local and international regulations.
  • Stay updated on regulatory changes (EMA, ICH guidelines) and ensure adherence for client projects.
  • Liaise with health authorities, clients, and internal teams, addressing regulatory queries and providing updates.
  • Maintain regulatory databases, documentation, and archives for accuracy and compliance.
  • Participate in regulatory strategy discussions to enhance project efficiency.

Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
  • 0-2 years of experience in regulatory affairs, quality assurance, or a related field.
  • Familiarity with EMA and ICH regulatory guidelines is a plus.
  • Excellent organizational skills and attention to detail.
  • Ability to manage multiple projects and meet tight deadlines.
  • Strong written and verbal communication skills in English (additional languages are a plus).
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • A proactive mindset with a willingness to learn in a fast-paced environment.

Join Excelya and gain invaluable regulatory affairs experience while contributing to impactful healthcare advancements!