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

Senior Director Global Regulatory Lead Early Clinical Development

Senior Director Global Regulatory Lead Early Clinical Development Our client, a global pharma company, are currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to joint their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global...

Location: Cork,
Senior Director Global Regulatory Lead Early Clinical Development 		Cork 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.