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Regulatory Affairs Executive – Vaf 190

Product Life Group
Product Life Group
3+ years
Not Disclosed
10 March 26, 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 (PLG)
Location: Ireland, UK (Remote Possible)
Category: Regulatory Affairs & Operations
Contract Type: Permanent

Purpose of the Role:
To complete regulatory and technical work related to human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.

Key Objectives:

  • Handle regulatory and technical work across various product categories.

  • Communicate effectively with regulatory authorities and notified bodies.

  • Contribute to process improvements within the Regulatory team.

Principal Responsibilities:

  • Regulatory Submissions:

    • Prepare regulatory submissions independently for medicinal products.

    • Handle new license applications, variations, responses to questions, and renewals.

  • Documentation and Technical Work:

    • Coordinate and review technical documentation.

    • Participate in medical device regulatory work.

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

  • Regulatory Support and Compliance:

    • Provide technical support within the regulatory framework.

    • Use and update regulatory information systems for planning, preparing, tracking, and storing submissions.

    • Perform administrative activities related to regulatory affairs.

  • Team Collaboration:

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

    • Support other duties assigned by the Board of Directors.

Experience, Background, and Knowledge:

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

  • Strong attention to detail and proofreading skills.

  • Ability to work effectively in a team environment.

Qualifications, Professional Memberships, and Licenses:

  • Degree in a science-based subject.

  • GCSE in Maths and English.