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Regulatory Affairs Director
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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.
- 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.