Regulatory Specialist

  • Galway
  • Permanent
  • JO-1609-61849_1545397288

Summary

Senior Regulatory Specialist
Responsibilities

  • Provide regulatory support to the site for products of responsibility
  • Support the plan and execution of regulatory strategies and priorities through effective partnerships with the site and global CMC product responsible scientists.
  • Maintain working knowledge of current and emerging government and worldwide requirements for initial registration, re-registrations and post approval changes. and evaluate impact to the site
  • Assure that filed information on current approved dossiers is kept updated.
  • Provide Regulatory support, guidance and advice, in terms of supportive data for filings
  • Review site technical reports when complete from Regulatory perspective -
  • Provide training to the site personnel regarding product registration requirements and applicable regulations and guidelines
  • Provide Regulatory support as required during HA inspections
  • Leverage off the global network in terms of Regulatory guidance and support for small molecules when required.
  • Review site change control to provide pre-read on impact to Clinical / commercial licences for proposed changes
  • Co-ordination of Health registration requests

Requirements

  • Degree in chemistry, chemical engineering, pharmacy, biological sciences or related discipline.
  • Min 5 Years' experience In the pharmaceutical industry -- Regulatory experience in research, development and / or manufacturing
  • 3 years regulatory / QA experience required in the pharmaceutical industry
  • Direct Experience with regulatory submissions desirable
  • Proven ability to effectively influence site and global personnel
  • Strong knowledge of regulatory and compliance guidelines within the pharmaceutical manufacturing




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