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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

๐Ÿš€ Now Hiring: Regulatory Affairs Specialist - Spain ๐Ÿ‡ช๐Ÿ‡ธ

๐Ÿ’ผ Position: Regulatory Affairs Specialist
๐Ÿข Industry: CRO - Scientific and Regulatory Affairs
๐Ÿ“ Location: Spain
โณ Job Type: Full-time

๐Ÿ”Ž 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.

๐Ÿ”‘ 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

๐Ÿ“Œ Requirements

๐ŸŽ“ Education:

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

๐Ÿ›  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

๐Ÿ’ป 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

๐ŸŽฏ Perks & Benefits

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

๐Ÿ“Œ Company: Innovaderm (Specialized in Dermatology CRO Research)
๐Ÿ“Œ Legal Requirement: Applicants must be legally eligible to work in Spain

๐Ÿ“ฉ Apply Now!