Regulatory Affairs Project Manager

Salary: OPen to negotiation Location: - From Home Kerry Remote Experience: 3+ years Job no: AKPharma0507Job Status: Full-Time

We are presently recruiting for a Regulatory Affairs Project Manager to work remotely for our clients in County Kerry. Your main duty is to provide support for the daily activities associated with global regulatory projects, Project managing marketing authorization applications internationally, dossier preparations and being responsible for regulatory filing. You will be responsible for the maintenance and filing of patents & patent renewals in EU, USA and internationally. Role includes co-ordinating appropriate studies to support patents & formulations development. This position is hybrid with scope for remote work once you can travel when and as required to my clients offices in County Kerry.

Responsibilities:

  • Project managing product life cycle regulatory issues including post marketing variations, amendments, renewals, etc. including all associated technical pharmaceutical studies
  • Lead reg team member of project team for new product development.
  • In conjunction with existing staff supporting the preparation of dossier files for marketing authorisations including Part 1/Admin sections, Part 2 CMC pharmaceutical sections including technical/scientific input on studies & creating and overseeing studies needed for pharmaceutical sections of dossier preparation
  • In conjunction with the quality team – Providing technical and regulatory input to quality & QA for documentation associated with existing product manufacture
  • Liaise as needed with CMO’s on regulatory matters, change controls, regulatory filing matters including studies for new licences or variations, change controls, and audits for regulatory compliance
  • Facilitate project status meetings and other meetings as required
  • Develop strong relationships with all stakeholders to create high-functioning global project teams
  • Establish project plans with associated milestones and deadlines
  • Identify, document, and facilitate resolution of project risks and issues
  • Oversee routing, tracking, and archiving of project documentation

Qualifications:

  • Possess the requisite expertise regarding the regulatory requirements for the Pharmaceutical Sector in the European Union demonstrated by a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned in, engineering or another relevant scientific discipline,
  • Four years of professional experience in regulatory affairs or in quality management systems
  • Ability to work independently and complete multiple assignments on time Knowledge and/or experience in International registrations and clinical studies is a plus.

Salary is open to negotiation depending on qualifications and experience. If you are interested please apply or email adrien@redchair.ie

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