Regulatory Affairs Consultant

• 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.

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