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Regulatory Affairs Executive – Vaf 190

3+ years
Not Disclosed
10 March 19, 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 Executive – VAF 190
Location: Ireland, UK (Remote Work Possible)
Department: Life Cycle - Regulatory Affairs & Operations
Contract Type: Permanent

Purpose of the Role:

To complete regulatory and technical work as required, covering human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.

Key Objectives:

  • Complete regulatory and technical work covering human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.

  • Communicate with regulatory authorities and notified bodies.

  • Contribute to regulatory team process improvements.

Principal Responsibilities:

  • Independently prepare regulatory submissions for medicinal products, including but not limited to:

    • New license applications.

    • Variations and renewals.

    • Responses to questions from regulatory authorities.

  • Coordinate and review technical documentation.

  • Contribute to regulatory work related to medical devices.

  • Write sections of Module 3 of dossiers and Quality Overall Summaries.

  • Provide technical support within the regulatory framework.

  • Participate in regulatory team meetings, manage assigned tasks/projects, and provide regular updates.

  • Use and update regulatory information systems to plan, prepare, track, and store submissions to regulatory agencies.

  • Perform administrative activities within the function.

  • Carry out other duties reasonably associated with the position as assigned by the Board of Directors.

Experience, Background, and Knowledge:

  • Minimum of 3 years of experience in a pharmaceutical regulatory role.

  • Ability to work effectively in a team.

  • Strong attention to detail and proofreading skills.

Qualifications, Professional Memberships, and Licences:

  • Degree in a Science-based subject.

  • GCSE Maths & English.