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Medical Regulatory Affairs Executive

Medical Regulatory Affairs Executive- Remote Ireland- 12 month contract

Key Responsibilities:

  • Compilation and submission of EU regulatory dossiers using National / MRP / CP/ DCP
    applications and submission / support ROW applications as required

  • Critical review and regulatory approval of all reports and documents associated with EU /
    ROW Marketing Authorisation (MA) and all MA life-cycle applications.

  • Advise and give guidance to R&D departments for the development regulatory required for
    dossier submissions in accordance with relevant requirements

  • Compilation of eCTD regulatory dossiers (Module 1 -5) for National and MRP/DCP Marketing
    Authorisation (MA) applications in an accurate and timely manner.

  • Liaise with and respond to queries raised by the regulatory authorities in a timely and
    accurate manner.

  • Review dossiers/responses prepared by/or on behalf of the company prior to submission
    as required.

  • Preparation and submission of renewal applications for existing MA’s.
  • Preparation and submission of variation applications to existing MA’s.
  • Review of in house supporting documentation to be included in a regulatory dossier.
  • Review of Active Substance Master Files (ASMF).
  • Review of protocols for Bioequivalence studies and Biostudy reports.
  • Preparation of Product Specification Files (PSF’s).
  • Auditing of CRO’s, monitoring of biostudies as required.
  • Writing of Quality Overall Summaries.
  • Artwork review and approval.
  • Transfer of data from the Regulatory Department to internal departments.
  • Work with the Qualified Persons Responsible for Pharmacovigilance (QPPV’s) in line with in house pharmacovigilance procedures and practices.
  • Organising regulatory payments and the recharging of costs to customers in a timely
    manner.

  • Address allocated department measurements in line with KPl’s.
  • Assist departments/affiliated companies/customers in technical queries and discussions.
  • Participate in conference calls to provide regulatory advice as required
  • Establishes strong working relationships with others, building team rapport and creating
    a cohesive team environment.
  • Strong Customer Service focus both internally and externally
  • Ability to collaborate cross-functionally and across geographies.
  • Ability to work on multiple projects simultaneously, to tight deadlines and on own initiative.
  • Takes a methodical, systematic and structured approach to organising work.
  • Good communication skills both written and orally.
  • Good technical knowledge of pharmaceutical products and processes
  • Escalates issues appropriately.

Education and Experience:

  • Scientific qualification and background -preferably B.Sc. or equivalent.
  • Minimum 3 -5 years in a regulatory/R&D environment preferably with experience in generic
    pharmaceutical applications.

  • Strong Customer Service focus both internally and externally
  • Excellent command of technical English (both written and spoken), with good verbal and
    written communication skills

  • Strong computer skills in MS Office, MS Excel, Power Point etc.

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Job Details

Galway
3 January 2024
Job ID: 9002

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