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Specialist, Regulatory Affairs (Poland)

2-3 years
Not Disclosed
10 Jan. 30, 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

🌍 Now Hiring: Specialist, Regulatory Affairs - Poland 🇵🇱

💼 Position: Regulatory Affairs Specialist
🏢 Industry: CRO - Regulatory Affairs
📍 Location: Poland
Job Type: Full-time

🔎 Job Overview

Innovaderm is seeking a Regulatory Affairs Specialist to join its expanding team. In this role, you will lead the preparation and submission of regulatory documents and clinical trial applications in compliance with EU CTR and other relevant regulations, ensuring adherence to timelines and quality standards.

🔑 Key Responsibilities

1. Regulatory Document Preparation

  • Prepare and submit CTA packages and regulatory documents to ensure compliance with EU CTR and other regulations
  • Coordinate timelines for EU, APAC, and North American submissions
  • Review regulatory submissions created by subcontractors to ensure high-quality standards

2. Stakeholder Communication

  • Serve as the point of contact for sponsors and subcontractors regarding regulatory submissions
  • Provide regulatory advice to project teams on local and EU submission strategies
  • Prepare and review patient information sheets, informed consent forms, and regulatory forms

3. Regulatory Intelligence & Support

  • Maintain up-to-date knowledge of EU CTR and local regulatory requirements in EU/EEA countries
  • Participate in project kick-offs, audits, and client meetings

📌 Requirements

🎓 Education:

  • Bachelor’s degree (or equivalent) in a scientific discipline

🛠 Experience:

  • Minimum of 2-3 years of regulatory affairs experience in CRO or Pharma (specifically within Poland)
  • Experience in preparing and submitting initial CTA and familiarity with CTIS
  • Previous experience in sponsor-facing roles is an asset

💻 Skills:

  • Excellent knowledge of EU regional/national regulatory guidelines (Poland, Spain, Germany, France, Netherlands)
  • Proficiency in GCP and ICH standards
  • Fluency in English (additional languages are a plus)
  • Excellent organizational and communication skills

🎯 Perks & Benefits

Flexible schedule and home-based position
Ongoing learning and development opportunities
Permanent full-time position with vacation benefits

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)

📩 Apply Now!