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Global Regulatory Affairs Manager - CMC

Global Regulatory Affairs Manager - CMC

  • Location

    Dublin, Republic of Ireland

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    20686_1588001990

  • Published:

    5 months ago

  • Expiry date:

    2020-05-27

  • Consultant:

    #

Job title: Global Regulatory Affairs Manager - CMC

A growing Biopharma in Central Dublin are seeking a Regulatory Affairs Manager with extensive CMC experience. This role will have the opportunity to work on exciting development and marketed products on a global scale.

Responsibilities:

  • Management of global regulatory affairs CMC lifecycle documentation
  • Coordinating planning, writing and reviewing CMC information for all regulatory compliance submissions and notifications
  • Coordinate the preparation of documents and publishing requests to support responses to regulatory agencies
  • Support EU, US and global commercial license maintenance

Requirements:

  • Minimum of three years Regulatory CMC experience
  • Knowledge of FDA, EMA and ICH guidelines.
  • Strong understanding of quality management systems including change controls, documentation management systems and experience with electronic Common Technical Document eCTD submission
  • BSc minimum

Salary and benefits:

A highly competitive annual salary, bonus, healthcare and pension are on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk