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 Executive – Vaf 190

Product Life Group
Product Life Group
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.