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Regulatory Affairs Specialist (Spain)

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: Regulatory Affairs Specialist - Spain 🇪🇸

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

🔎 Job Overview

We are looking for a Regulatory Affairs Specialist to join Innovaderm. You will be responsible for preparing and submitting regulatory documentation to ensure compliance with EU regulations, ensuring timely and high-quality submissions for clinical trials. This position offers you the opportunity to provide leadership in all regulatory activities for clinical trial startup in the EU and beyond.

🔑 Key Responsibilities

1. Regulatory Document Preparation & Submission

  • Prepare and submit regulatory documents (CTA packages) for clinical trials in assigned countries, ensuring compliance with regulations
  • Review submissions created by subcontractors (CROs, regulatory vendors) before submission to the Clinical Trial Information System (CTIS)

2. Coordination & Communication

  • Oversee regulatory timelines for EU (mainly), APAC, and North America submissions
  • Act as the point of contact for Sponsors and subcontractors regarding regulatory submission activities
  • Support project teams with regulatory advice and local requirements

3. Document Management & Review

  • Prepare and review patient information sheets, informed consent forms, and regulatory templates
  • Manage translation requests with vendors
  • Maintain a regulatory intelligence database and ensure current knowledge of regulations

4. Project Involvement

  • Participate in kick-off meetings, audits, and project meetings related to regulatory affairs

📌 Requirements

🎓 Education:

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

🛠 Experience:

  • Minimum of 2-3 years of clinical research experience in CRO or pharmaceutical regulatory affairs
  • Experience with initial Clinical Trial Applications (CTAs) is essential
  • Experience in sponsor-facing roles and familiarity with CTIS is a plus

💻 Skills:

  • Excellent knowledge of EU regulatory guidelines (Spain, Poland, Germany, France, Netherlands)
  • Knowledge of GCP and ICH standards
  • Fluency in English (oral and written); additional languages are an asset
  • Strong organization, communication, and attention to detail
  • Ability to manage multiple tasks and meet deadlines

🎯 Perks & Benefits

Flexible work schedule
Permanent full-time position
Home-based position
Vacation and ongoing learning opportunities

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)
📌 Legal Requirement: Applicants must be legally eligible to work in Spain

📩 Apply Now!