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QA Manager
Dublin West
Snr QA Specialist
Dublin South
Snr QA Officer
Dublin North
Buyer
Cork
Biostatistician
Dublin City Centre
Program Manager
Westmeath
Senior CRA
Dublin
QA Manager Biologics
Dublin West
Head of Quality
Dublin West
R&D Engineer
Galway
Product Specialist (Microbiology)
Republic of Ireland
API Purchaser
Dublin
QA Manager
Meath
R&D Engineer
Dublin
QA Manager
Dublin North
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Regulatory Affairs Consultant
Job Title. Location Salary Actions

Regulatory Affairs Manager

Regulatory Affairs Manager Our client requires a Regulatory Affairs Manager to joint their team. The ideal candidate will have excellent experience in the are

Location: Kerry,
Regulatory Affairs Manager
Kerry Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client requires a Regulatory Affairs Manager to joint their team on a permanent basis. The ideal candidate will have excellent

Location: Kerry,
Regulatory Affairs Manager
Kerry Not Disclosed

Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST Our client a Galway based medical device start up company is recruiting an RA Specialist. The successful candidate will work on

Location: Galway,
Regulatory Affairs Specialist
Galway Not Disclosed
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Regulatory Affairs Manager Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Regulatory Affairs & Labelling Specialist Tipperary Not Disclosed
Regulatory Affairs Manager Dublin Not Disclosed
Regulatory Affairs & Labelling Specialist Tipperary Not Disclosed
CMC Regulatory Affairs Director Dublin Not Disclosed
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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.