Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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!