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Search Results for Regulatory Affairs Consultant
Job Title. Location Salary Actions

Regulatory Affairs Manager (EMEA)

A Regulatory Affairs Manager (EMEA) is required to join a leadingMedical Device organisationin Athlone . Your role: As the Regulatory Affairs Manager you will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for company products globally. Your responsibilities: Primary responsibility for regulatory affairs in the EMEA region. Pursue relevant information pertaining to new developments in regulatory affairs by maintaining contact w...

Location: Roscommon,
Regulatory Affairs Manager (EMEA)
Roscommon Not Disclosed

Senior Associate Regulatory Affairs

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. This is an excellent position fo

Location: Dublin,
Senior Associate Regulatory Affairs
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
GMP Inspector (Compliance ) Dublin Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs & Quality Manager Dublin Not Disclosed
GCP/Pharmacovigilance Inspector Dublin Not Disclosed
Scientific Communications Publication Capability Lead Cork Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed

Regulatory Affairs Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

  • Degree minimum in a relevant area.
  • Significant experience in Regulatory setting (CRO / Medical Device / Pharma / Biotech).
  • Team player and client-focussed.